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Experience Level
Mid to Senior
Qualifications
A completed degree in a technical or natural science field (e.g., Medical Technology, Pharmaceutical Technology, Pharmacy, Chemistry, Chemical Engineering, Process Engineering, Biotechnology, Materials Science, or Life Sciences) or equivalent qualifications.Solid knowledge and several years of professional experience in Regulatory Affairs, ideally in the context of medical device approvals.Excellent understanding of current regulatory requirements (e.g., MDR 2017/745, ISO 13485, ISO 14971, 21 CFR 820).A strong quality awareness.Fluent in English, both written and spoken.Strong teamwork and communication skills, alongside high commitment and resilience.Ideally, some leadership experience.
About the job
As a Team Lead in Regulatory Affairs (m/w/d), you will ensure the availability of our pharmaceutical primary packaging solutions for patients across various parts of the world.
Your role involves supporting our clients with the approval of finished medicinal products by managing, implementing, and ensuring sustainable registration of our offerings. As a subject matter expert, you will engage directly with our customers, significantly contributing to our company's success.
Your Responsibilities
Lead the Regulatory Affairs team in Bünde with disciplinary responsibility.
Oversee the creation, maintenance, and enhancement of technical documentation for our portfolio of pharmaceutical primary packaging in accordance with MDR 2017/745 Article 117 and Annex I.
Prepare and submit international product registrations for primary packaging (e.g., US FDA, Health Canada, NMPA (CFDA), CDSCO).
Support the implementation of regulatory requirements throughout the entire process chain for both existing and innovative projects.
Analyze and evaluate regulatory changes and developments.
Review specifications and changes within the scope of change management.
Collaborate interdisciplinary with various interfaces within the organization and across locations.
About Gerresheimer AG
Gerresheimer is an innovative system and solution provider and a global partner for the pharmaceutical, biotech, and cosmetics industries. The group offers a comprehensive portfolio of drug containment solutions including closures and accessories, drug delivery systems, medical devices, and health sector solutions. Our range of services includes digital solutions for therapy support, on-body devices, syringes, pens, autoinjectors, inhalers, as well as vials, cartridges, ampoules, tablet containers, infusion, drop, and syrup bottles. Gerresheimer ensures that medications are safely delivered to patients and administered reliably. We support our clients with extensive services along the value chain while addressing the growing demand for more sustainability. With over 40 production sites in 16 countries across Europe, America, and Asia, Gerresheimer is globally present and continuously expanding its footprint.
Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.
Unlock Your Potential
Generate Job-Optimized Resume
One Click And Our AI Optimizes Your Resume to Match The Job Description.
Is Your Resume Optimized For This Role?
Find Out If You're Highlighting The Right Skills And Fix What's Missing
Experience Level
Mid to Senior
Qualifications
A completed degree in a technical or natural science field (e.g., Medical Technology, Pharmaceutical Technology, Pharmacy, Chemistry, Chemical Engineering, Process Engineering, Biotechnology, Materials Science, or Life Sciences) or equivalent qualifications.Solid knowledge and several years of professional experience in Regulatory Affairs, ideally in the context of medical device approvals.Excellent understanding of current regulatory requirements (e.g., MDR 2017/745, ISO 13485, ISO 14971, 21 CFR 820).A strong quality awareness.Fluent in English, both written and spoken.Strong teamwork and communication skills, alongside high commitment and resilience.Ideally, some leadership experience.
About the job
As a Team Lead in Regulatory Affairs (m/w/d), you will ensure the availability of our pharmaceutical primary packaging solutions for patients across various parts of the world.
Your role involves supporting our clients with the approval of finished medicinal products by managing, implementing, and ensuring sustainable registration of our offerings. As a subject matter expert, you will engage directly with our customers, significantly contributing to our company's success.
Your Responsibilities
Lead the Regulatory Affairs team in Bünde with disciplinary responsibility.
Oversee the creation, maintenance, and enhancement of technical documentation for our portfolio of pharmaceutical primary packaging in accordance with MDR 2017/745 Article 117 and Annex I.
Prepare and submit international product registrations for primary packaging (e.g., US FDA, Health Canada, NMPA (CFDA), CDSCO).
Support the implementation of regulatory requirements throughout the entire process chain for both existing and innovative projects.
Analyze and evaluate regulatory changes and developments.
Review specifications and changes within the scope of change management.
Collaborate interdisciplinary with various interfaces within the organization and across locations.
About Gerresheimer AG
Gerresheimer is an innovative system and solution provider and a global partner for the pharmaceutical, biotech, and cosmetics industries. The group offers a comprehensive portfolio of drug containment solutions including closures and accessories, drug delivery systems, medical devices, and health sector solutions. Our range of services includes digital solutions for therapy support, on-body devices, syringes, pens, autoinjectors, inhalers, as well as vials, cartridges, ampoules, tablet containers, infusion, drop, and syrup bottles. Gerresheimer ensures that medications are safely delivered to patients and administered reliably. We support our clients with extensive services along the value chain while addressing the growing demand for more sustainability. With over 40 production sites in 16 countries across Europe, America, and Asia, Gerresheimer is globally present and continuously expanding its footprint.