sebamed sucht in eine/n Regulatory & Safety Affairs Manager (ID-Nummer: 13315250)
Lead, Develop and Empower the Team Provide strong technical leadership, foster professional development and ensure continuous growth and engagement of your team. Manage External Service Providers Effectively manage external service providers acting on behalf of CHEPLAPHARM, ensuring quality, compliance and performance.
WR Group GmbH sucht in eine/n Head of (m/w/d) Regulatory Affairs / Regulatory Affairs Manager in der Gesundheitsbranche (Pharmazeut, Chemiker, Biologe o. ä.) (ID-Nummer: 13666361)
Union Investment sucht in eine/n Data Scientist & Regulatory Affairs Manager*in (ID-Nummer: 13764691)
KEYMKR GmbH sucht in Lübeck eine/n Regulatory Affairs Manager (m/f/d) (ID-Nummer: 13023224)
UROMED Kurt Drews KG sucht in eine/n Regulatory Affairs Manager (m/w/d) (ID-Nummer: 13723958)
ZEISS sucht in eine/n Manager Labeling & Regulatory Projects (f/m/x) (ID-Nummer: 13753083)
BEC Medical GmbH sucht in eine/n Innovativer Qualitätsmanager / Regulatory Affairs Manager Medizinprodukte (Mensch) (ID-Nummer: 13669004)
Allergopharma GmbH & Co. KG sucht in Reinbek eine/n Regulatory Affairs Manager CMC (m/w/d) (ID-Nummer: 13723465)
Christeyns GmbH sucht in eine/n Regulatory Affairs Manager (m/w/d) für die Region DACH (ID-Nummer: 13714408)
Ascend GmbH sucht in Frankfurt am Main eine/n Regulatory Affairs Manager (m/w/d) - Pharmazeutika (Generika) (ID-Nummer: 13548748)
Lohmann & Rauscher GmbH & Co. KG sucht in eine/n Regulatory Affairs Manager Clinical & Biological Evaluation (m/w/d) (ID-Nummer: 13715856)
Zur Verstärkung unseres Teams der Abteilung Regulatory Affairs suchen wir am Standort Bremen einen (Junior) Regulatory Affairs Manager (m/w/d) in Vollzeit. Die Position ist unbefristet. Deine Aufgaben Erlangung und Aufrechterhaltung von internationalen Produktzulassungen Erarbeitung von Zulassungsstrategien für neue Medizinprodukte nach länderspezifischen Vorgaben Kommunikation und enge Zusammenarbeit mit nationalen und internationalen Zulassungsbehörden Laufende Recherche regulatorischer Neuerung und Änderungen zu landesspezifischen Zulassungsanforderungen Dein Profil Abgeschlossenes naturwissenschaftliches, rechtswissenschaftliches oder technisches Studium Erfahrung im Bereich Regulatory Affairs sowie Kenntnisse relevanter Normen und Gesetze (MDR, ISO 13485) sind von Vorteil Ausgeprägtes Verständnis für regulatorische und rechtliche Rahmenbedingungen Gute Deutsch- und Englischkenntnisse in Wort und Schrift, weitere Sprachkenntnisse wünschenswert Sicherer Umgang mit MS Office Eine selbständige, strukturierte und sorgfältige Arbeitsweise, kombiniert mit einer hohen Lernbereitschaft und sehr guten kommunikativen Fähigkeiten BEGO ist ein Familienunternehmen, bei dem das Miteinander an erster Stelle steht.
Zur Verstärkung unseres Teams der Abteilung Regulatory Affairs suchen wir am Standort Bremen einen Senior Regulatory Affairs Manager (m/w/d) in Vollzeit. Die Position ist unbefristet. Deine Aufgaben Erarbeitung von Zulassungsstrategien und eigenverantwortliche Planung und Betreuung regulatorischer Vorgänge zur Erlangung und Aufrechterhaltung von internationalen Produktzulassungen Termingerechte Erstellung bzw.
Deutsches Institut für Zell- und Gewebeersatz gGmbH sucht in eine/n Senior Regulatory Affairs Manager* (m/w/d) / Non-profit-Pharmaunternehmen (ID-Nummer: 13676018)
Manufacturing, Sales, Sourcing and Technical Departments Accountable for ensuring the quality of all locally sourced and manufactured products and for the compliance to food, HACCP and FSSC/ISO standards Developing regulatory strategy in the Europe region and establishing the framework for the provision of strategic advice and recommendations on legislative development in line with business requirements Building and maintaining critical relationships with key decision makers and stakeholders, both internally and externally Taking the lead in responsibility for all quality & food safety issues and ensuring crisis management when necessary Working closely together with Fonterra’s global network, including New Zealand and US Reporting to the Director Supply Chain and FSQR of Fonterra Europe YOUR PROFILE BSc or MSc degree in Food Science & Technology or similar Senior management experience in Quality Assurance, Food Safety and Regulatory Affairs in a comparable international business, preferably in food, feed or pharma Knowledge of various international food safety and quality systems Relevant project management experience, preferably in manufacturing Understanding of EU food regulatory environment Able to deal with and manage complexity, building strong relationships, striving for solutions and results Excellent influencing, stakeholder management and communication skills with fluency in English Comfortable working and travelling (up to 20%) in an international environment; possibility for hybrid working, max. two days/week from home office Personal skills: strategic vision, business acumen, customer focus, entrepreneurial, natural leader, decisiveness and team player FURTHER INFORMATION AND APPLICATION If you are interested in this position , please contact Jakob Jan Verbraak via email jakobjan@dupp.nl or phone+31 6-51820349 /+31 317-468686.
x1F GmbH sucht in eine/n Manager SAP Banking (m/w/d) im Team Finance, Risk and Regulatory Reporting (ID-Nummer: 13752733)
regenold GmbH sucht in eine/n Regulatory Affairs Manager (m/f/d) in-vitro diagnostic medical devices / CDx I 80-100% (ID-Nummer: 13764773)
The sales office for the AMEAP region is located in Dubai. For the region Europe & AMEAP we are searching for a Manager Regulatory Affairs & Product Labelling, to be based in The Netherlands or at one of the European locations. YOUR ROLE Responsible for compliance of Dawn Foods products with all relevant food legislation in the European and AMEAP markets; this involves raw materials, recipes, labels and other forms of communication Managing and coaching the teams for both Regulatory Affairs (9 employees) and Product Labelling (6 employees) across the various international locations Embedding the regulatory function as integral part of product management, product development, procurement, production and quality assurance processes; risk assessment of new legislation on manufactured and marketed products Contributing to certification audits in close cooperation with Quality Assurance with respect to product specifications and compliance Ensuring that all product labels are compliant with relevant food legislation in the various countries.
Ensure high-quality, data-driven deliverables that meet the highest standards of medical, ethical, and scientific integrity and conduct. Propose strategies to manage and accelerate timelines for drug development strategies. Identify, promote, and develop innovation in pharmaceutical product development.
We currently offer the exciting opportunity to join the team as Clinical Trial Manager (m/w/d) in full-time and work home-based throughout Germany. In this role you will be accountable for the operational management of the component of clinical trials.
We bring together sector expertise, global scale and local knowledge to design and manage supply chains from raw materials and manufacturing through to the delivery of finished goods and return services. And by seamlessly connecting local operations across the world we are able to deliver the future of global trade.
Successful studies in Engineering, Business Administration or Life Sciences (MS/MBA/BS/BA or equivalent) Solid experience in managing major capital projects in the pharmaceutical industry Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility Excellent understanding of project management principles and project lifecycle phases, including knowledge of Validation, CMC and facility regulatory submission requirements Experience to manage high level project budgets Ability to handle many tasks simultaneously and integrate project planning efforts across functions Ability to understand the big picture and approach problem solving in a proactive team manner German knowledge is mandatory Varied work in a renowned companyPleasant working atmosphereSupport throughout the entire application processLook forward to working in an international environment Ihr Kontakt Ansprechpartner Sandro Frei Referenznummer 865163/1 Kontakt aufnehmen E-Mail: sandro.frei@hays.ch Anstellungsart Freiberuflich für ein Projekt
Identification and implementation of timeline optimizations and escalation of important topics to leadership. Manage Key External Stakeholders The Integration Project Manager is ultimately accountable for ensuring external stakeholders Divestment Partner, Contarct Manufacturing Organizations, Sales and Distribution Partners are effectively managed and aligned with integration objectives.
Joining the team provides the opportunity to work with one single client and to manage clinical research projects in different therapeutic areas. We currently offer the exciting opportunity to join the team as Local Trial Manager (m/w/d) in full-time and work home-based throughout Germany.
Lead the full sales cycle from first contact to contract signature. Establish and manage international sales channels, partner networks, and key accounts. Conduct negotiations at C-level with OEMs, Tier-1s, and enterprise customers.
YOUR PROFILE BSc or MSc degree in Food Science & Technology or similar Senior management experience in Quality Assurance, Food Safety and Regulatory Affairs in a comparable international business, preferably in food, feed or pharma Knowledge of various international food safety and quality systems Relevant project management experience, preferably in manufacturing Understanding of EU food regulatory environment Able to deal with and manage complexity, building strong relationships, striving for solutions and results Excellent influencing, stakeholder management and communication skills with fluency in English Comfortable working and travelling (up to 20%) in an international environment; possibility for hybrid working, max. two days/week from home office Personal skills: strategic vision, business acumen, customer focus, entrepreneurial, natural leader, decisiveness and team player FURTHER INFORMATION AND APPLICATION If you are interested in this position, please contact Jakob Jan Verbraak via email info@dupp.nl or phone +31 317-468686 /+31 6-51820349 .
Job Overview: As an Associate Director, Biostatistics, with regional/site presence, you will manage a team of Biostatistics staff and fulfil the role of site head or functional head within a site. You will provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work.
If you would like to contribute to this diverse and ambitious team, we look forward to receiving your application! What makes your day with us special: Develop and Manage Regional Distributor Partnerships Build, maintain and strengthen long-term relationships with regional distributors across Western Europe.
If you would like to contribute to this diverse and ambitious team, we look forward to receiving your application! What makes your day with us special: Develop and Manage Regional Distributor Partnerships Build, maintain and strengthen long-term relationships with regional distributors across Asia Pacific.
If you would like to contribute to this diverse and ambitious team, we look forward to receiving your application! What makes your day with us special: Develop and Manage Regional Distributor Partnerships Build, maintain and strengthen long-term relationships with regional distributors across Middle East Africa.
The Clinic Operations Manager works in close partnership with the GM to align operational delivery with the clinic’s strategic and commercial objectives. The General Manager (GM) retains full accountability for financial performance, budgeting, commercial strategy, and overall clinic risk.
We are looking for a skilled Engineering Project Manager (m/f/d) to lead and coordinate technical development projects related to Grid Code Compliance for wind turbines. In this role, you will be responsible for ensuring that our turbine platforms meet the latest regulatory requirements across various global markets.
We are looking for a skilled Engineering Project Manager (m/f/d) to lead and coordinate technical development projects related to Grid Code Compliance for wind turbines. In this role, you will be responsible for ensuring that our turbine platforms meet the latest regulatory requirements across various global markets.
Refund Services Product Manager (gn) - Location Romania Your job at DKV Mobility? As part of a leading European B2B platform for on-the-road payment solutions, you will work in an exciting environment.
Quality Assurance / QA Manager (m/w/d) HIER WERDEN SIE ARBEITEN: Unser Mandant ist ein international tätiger Logistikdienstleister mit Hauptsitz in Belgien mit langjähriger Tradition und familiären Werten.
YOUR NEW CHALLENGE You lead the sale of FoodChain ID services across key customers and prospects in the DACH region You are responsible for developing and maintaining high value customer relationships and for acquisition of customers and prospect businesses to maximize the opportunity You actively cooperate with internal stakeholders to guide in the development of strategic plans You provide “Voice of the Client” feedback on market needs and company service delivery WHAT TO BRING Some years of experience as a Key Account Manager in B2B sales in the DACH region, selling products that require explanation (preferably digital services) to big and medium sized food companies You are preferably knowledgeable in quality subjects, such as Food Safety, Testing and Certification You bring experience in managing complex customers and a network of decision makers as a plus You are a “hunter” personality with strong communication and negotiation skills, able to understand your customer needs, open-minded as well as with a proactive approach, self-confidence and resilience THE OFFER FOR YOU FoodChain ID relies on personal responsibility and ownership.
The Deputy Laboratory Manager will support the Laboratory Manager in the delivery of the service and management of the laboratory team. This is a full-time role working 37.5 hours per week - weekend rotation will be required at approximately 1:4 Key Responsibilities: Full range of clinical procedures, including ICSI, vitrification and PGT Communicating with patients about treatment options and results Quality Management, including supporting with audit, document control, non-compliance, quality control/assurance.
The Deputy Laboratory Manager will support the Laboratory Manager in the delivery of the service and management of the laboratory team. This is a full-time role working 37.5 hours per week - weekend rotation will be required at approximately 1:4 Key Responsibilities: Full range of clinical procedures, including ICSI, vitrification and PGT Communicating with patients about treatment options and results Quality Management, including supporting with audit, document control, non-compliance, quality control/assurance.
Für unsere Neugründung innerhalb der FUTRUE Gruppe suchen wir ab sofort einen Venture Manager – Brain-Computer-Interfaces (w/m/d), der mit uns bis 2030 die führende Generation von Brain-Computer-Interfaces entwickelt und so die Grenzen der Medizin neu definiert.
-Ing., or higher)Solid proven project management and leadership experience in mid-sized, complex CapEx projects within the chemical, biotech, or pharmaceutical industryStrong project management skills, including expertise in contract management, cost control, and stakeholder managementDemonstrated experience in process and infrastructure engineering in chemical, biotech, or pharmaceutical environmentsSolid understanding and practical experience with cGxP requirements as well as qualification and validation processesFluent in German and English, both written and spokenProven leadership capabilities with the ability to guide teams and manage departmental responsibilities A highly motivated team and an open way of communication A very renowned companyGood infrastructurePossibilities to work remoteTips on how to prepare a successful application Ihr Kontakt Referenznummer 865168/1 Kontakt aufnehmen Telefon:+41 44 225 50 00 E-Mail: positionen@hays.ch Anstellungsart Freiberuflich für ein Projekt
Category Manager/ Produktmanagement (m/w/d) medizinische Investitionsgüter Vollzeit (38,5h / Woche), flexible Arbeitszeiten, Homeoffice (bis zu 2 Tage/ Woche) Ein Job, der nicht nur Spaß macht – sondern vor allem Sinn.
YOUR PROFILE You are an experienced B2B marketeer, business developer, product manager or indus-try/business analyst with a strong track record from the chocolate and confectionary industry or a related industry. Insights into the industry on an international level – product lines, key players and markets is a high priority.
Participate in research projects as needed. Communication: Attend lab/clinic meetings as directed by Lab Manager. Ensure effective communication with other departments and TFP. Participate in patient information events and represent TFP at industry conferences.
We look forward to hearing from you! Act as independent Finance Manager and financial leader for the assigned region, overseeing accounting functions and ensuring accurate and timely financial processes Monthly Management Reporting: Lead and coordinate the preparation of monthly management accounts, delivering results punctually while meeting stringent corporate deadlines Budgeting and Forecasting: Drive the preparation of annual budgets and rolling forecasts.
We look forward to hearing from you! Act as independent Finance Manager and financial leader for the assigned region, overseeing accounting functions and ensuring accurate and timely financial processesMonthly Management Reporting: Lead and coordinate the preparation of monthly management accounts, delivering results punctually while meeting stringent corporate deadlinesBudgeting and Forecasting: Drive the preparation of annual budgets and rolling forecasts.
This involves the patients’ sense of care, control, value and cost in a broad sense. · To manage situations in the nursing/sonography area not covered by standard operating procedures. · To contribute to the holistic approach to patient care that the clinic endeavors to provide
What you will do: Prepare and structure topics, requirements, and stakeholder requests Answer stakeholder questions and create clear, reliable documentation Support and drive new projects from concept phase to implementation Manage and refine incoming requests via the team’s ticketing workflow Derive and define development tasks based on business and data needs Analyze data flows and assess the impact of changes on existing data deliverables Evaluate new data sources and identify opportunities for process optimization Ensure transparency and quality of KPIs and financial data Who you are: 1+ years of experience in a Technical Business Analyst, Data, or similar role Hands-on mentality and strong willingness to learn Experience working with data and IT systems Solid SQL skills (BigQuery is a plus) Understanding of data structures and data flows Basic programming knowledge is a nice to have Additional information: **Working model: Due to the upcoming tasks and responsibilities for this position, it is required to work onsite at our headquarters in Hamburg or Berlin on a weekly basis.
Main job duties: -To take full leadership, operational and financial responsibility for managing a safe, efficient operational standards and profitable site for the organization and the customer(s), -Take full responsibility for managing and running a safe operation and driving a Safety First Culture with all individuals on site by applying and improving the Safety Standards, -Align Objectives & KPIs applicable to your team and consider how these have an impact on site results, including the required frequency for tracking them, how the results are calculated, ensuring the right ownership of each role in the operation, -Align volume forecast with customer and review monthly resource planning with Operations Manager, developing a work strategy for next month / period, including peaks and valleys' seasons, -Track Site Performance understanding the causes for the gap between them, understanding the financial and customer impact resulted by this gap and address actions with Operations Managers to improve it, -Ensure that Standard Operational Procedures (SOP) and Work Instructions (WI) of operational processes are up to date, available at relevant place for employees and that employees are working according to the standard established, via OMS Confirmation, -Ensure your Shift Managers are properly trained according to their training matrix and enable their training and coaching sessions to enhance their personal development - via training matrix and schedule, -Discuss and approve improvement actions that involve customer requirements and SLA's, additional resources and financial investments with the operations managers, support the team during the implementation of improvement actions, -Promote the continuous improvement culture and sustainability of the program with operations managers and their teams, -Participate in a Monthly Results Meeting with the entire leadership team and employees, presenting the site's results, priorities and promoting engagement within the team, -Control your operational processes (inbound, picking, outbound, etc), fulfilling service level agreeded and deadlines established, -Provide leadership for the site in assessing potential, developing talent and succession planning, lead by example, -Ensure adequate security measures are in place to protect the site premises, including the safety of personnel, DSC assets and of the customer's product, -Maintain processes and required statutory qualifications to ensure compliance with all relevant regulatory and local legal obligations, -Act as the first point of contact for the customer relating to site operation matters and build a good relationship to develop trust and ensure strong engagement, -Conduct regular reviews (e.g. monthly) with customer on operational performance and delivery against the agreed KPIs, -Identify and propose opportunities to grow the business with existing customers, -Support Business Development / Account Management on contractual and commercial issues and customer renewal planning.
Develop and execute strategies to enhance advocacy and engagement among key eye-care providers, ensuring alignment with overall brand and commercial objectivesDesign and implement training approaches that enable local SSCs to identify, recruit, and cultivate strong relationships with KOLs within their regionsBuild and sustain robust relationships with the ophthalmic medical community- including academic institutions and specialized physicians-using a scientific, needs-based approach to deliver targeted solutionsConduct an annual needs assessment for KOL activities and create regional execution plans in collaboration with key internal stakeholders; provide leadership with ongoing progress updates on the impact of regional KOL initiativesContribute to the development of advanced communication programs to ensure KOLs receive timely updates on company developments, products, and clinical dataOversee and maintain the regional KOL database to ensure accuracy, completeness, and effective engagement tracking through honoraria; annually update contracted HCP biographies and publications, ensuring all documentation remains current; deliver periodic utilization and budget reports to the Global KOL DirectorAct as the primary liaison with the legal department to develop and manage KOL contracts and service agreements in full compliance with regulatory requirements; coordinate and process all onboarding documentationPlan, coordinate, and execute approved regional advisory boards in support of KOL Management and the Chief Medical OfficerRepresent the company at regional medical congresses and scientific meetings, supporting KOL strategy execution and identifying emerging key influencersServe as an internal expert on disease state and product knowledge, empowering internal and field teams to better understand clinical needs, strengthen KOL loyalty, and foster broader adoption within the ophthalmic communityCollaborate closely with internal teams-including Marketing, R&D, and Professional Education—to address cross-functional KOL needs and ensure smooth coordination of activities Solid direct experience working with Key Opinion Leaders, ideally within the ophthalmology sector Exceptional communication and interpersonal skills, with the ability to build trust-based relationships across diverse stakeholder groupsFull professional proficiency in English, both spoken and writtenStrong business acumen and a demonstrated ability to effectively manage timelines, processes, and procedural workflowsExperience with product launches, advisory boards, and post-approval studies is highly advantageousRelevant academic background required (e.g., life sciences, healthcare, business, or a related field) A very renowned companyOther Locations: Oberkochen/Jena/Berlin Ihr Kontakt Referenznummer 865508/1 Kontakt aufnehmen Telefon:+ 49 621 1788-4297 E-Mail: positionen@hays.de Anstellungsart Anstellung bei der Hays Professional Solutions GmbH