Sr Regulatory Affairs Expert

vor 1 Monat

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**:We are actively seeking a Senior Regulatory Affairs - Medical Device professional to join our dynamic team at Darmstadt. As a hybrid role with mínimal supervision, you will manage 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. You will autonomously compile and maintain technical files and other relevant regulatory documentation to guarantee timely registrations and renewals. YOu will also perform surveillance and advocacy activities for medical devices according to assigned tasks and provide support and counsel in tasks pertaining to regulatory registrations, listings, and compliance, with specific emphasis on adhering to the Medical Device (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR); maintaining compliance with requirements of FDA 21 CFR 600 & 820, ISO 13485:2016, and other applicable International Medical Device Regulations. In this role you ,anage regulatory review for CAPA investigations, adverse events, validations, and general projects (removed printed materials & added adverse events) and support preparation of and participate in audits by regulatory authorities and customers. You are responsible for regulatory review of labeling materials including labels, instructions for use, package inserts promotional materials and provide consultancy to ensure regulatory compliance and support new product development projects through regulatory assessments. You will aslo address regulatory queries and requests from both internal stakeholders and external customers and act as regulatory contact for other departments at the site.

**Who you are**:

- Master's or Bachelor degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science field with 4+ years experience in medical device/IVD regulatory affairs
- Minimum 4 years' experience in medical device and in-vitro diagnostics regulations (MDD/MDR IVDD/IVDR and US FDA)
- Experience with the implementation of Economic Operator requirements
- Experience with handling tasks from different sites, alignment and prioritization of it
- Experience in interpretation of regulations, guidelines, policy statements, etc. and in interfacing with relevant regulatory authorities
- Advanced written, and interpersonal communication skills including proficient knowledge of medical terminology
- Excellent organizational, prioritization, and problem-solving skills
- Excellent project management skills
- Capability to work independently while adeptly handling multiple tasks/projects with varying deadlines and specifications
- Proficient in MS Office Software (Word, Excel, PowerPoint)
- Competence in thriving within both collaborative team environments and individual work settings with mínimal oversight
- Excellent written and verbal communication skills and fluency in English and German

**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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