Director Regulatory Affairs Medical Devices(All

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 unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your Role**:We are looking for an experienced Director Regulatory Affairs Medical Devices (all genders) who will be responsible for the regulatory strategy of our medical device business and leading the Regulatory Affairs team within Bioelectronics. As the Director Regulatory Affairs, you will have a key role in building global regulatory plans that strengthen our market position and meet our business objectives. You will develop the regulatory paths for novel implantable neurostimulation devices and innovative digital healthcare solutions. In this role, you will manage and oversee our teams related to the design process, the communication with global regulators, as well as various regulatory submissions of highly innovative class III medical devices (CE-mark, FDA 510K or PMA). In close interaction with our Healthcare regulatory organization, you will ensure regulatory compliance, prepare country registrations and provide guidance to the leadership team. In close alignment with the VP & Head of Bioelectronics you will be accountable for the success of our Bioelectronics business at the current frontier of medicine at our headquarters in Darmstadt.

**Who you are**:

- PhD or Masterinalifescience, engineering or related discipline
- Minimum of 10 years experience working in Regulatory Affairs within medical device environments, with min. 5 years track-record successfully managing Regulatory Affairs teams bringing products to market
- Strong track record in leading teams in global regulatory matters of implants (class 3 medical devices) and Software as a Medical Device (SaMD)
- Proven expertise in compiling FDA and other regulatory submissions (Pre-IDE, IDE, 510(K), PMA, Design Dossier)
- Good understanding of the clinical development process, trial design aspects, and relevant clinical regulatory frameworks such as ICH, GCP, MDR, MPDG
- Strong team player; able to work within a highly multidisciplinary environment
- Effective communication with team members and stakeholders with diverse backgrounds
- Fluency in English required, German language knowledge desirable.

**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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