Head of Regulatory Medical Devices-europe

vor 2 Wochen

Darmstadt, Deutschland Merck KGaA Darmstadt Germany Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginablewith us.

**Your Role**:As Head of Regulatory Medical Devices - Europe you manage the Europe team reporting directly to you. Under your supervision will be Subject Matter Experts working on the assigned regulatory tasks related to health authority notifications, submissions, and registrations regarding renewals and new products, and changes to products or sale of products in new territories ensuring continual compliance to all applicable regulations and ensuring that site regulatory strategy aligns with overall corporate regulatory strategy, goals, and objectives. In this role you will independently assemble and maintain technical files and other regulatory documentation to ensure timely registrations and renewals. You will also maintain library/database of technical documentation.

Further this role requires to monitor the status of standards and regulations and conduct a review and analysis in case if requested. You will assist and advise in activities related to regulatory registrations, listing, and regulatory compliance, with particular focus on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR; maintaining compliance with requirements of FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other applicable International Medical Device Regulations. You will review updated documentation requirements and carry out documented review, ensuring any necessary updates are made, disseminate relevant information throughout the site as well as manage regulatory review for CAPA investigations, adverse events, validations, and general projects. Further you will support preparation for and participate in audits.

**Who you are:
- Master's degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science discipline
- 3+ years of personal management experience
- 3+ years of professional experience in Regulatory Affairs (IVD)
- Experience with in-vitro diagnostics
- Excellent organizational, prioritization and problem-solving skills
- Excellent project management skills

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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