Solventum is hiring an Associate Director, Regulatory Affairs to join our team. You will lead and develop a regulatory affairs team for the Dental Solutions Business, providing crucial expertise in EU MDR compliance and supporting global submissions. This role drives operational and strategic regulatory execution with a focus on speed, quality, and innovative approaches.
What You'll Do
- Lead and develop a team of individuals located at our Seefeld Germany plant, for the Dental Solutions Business.
- Provide expertise in developing EU MDR compliant technical documentation, including expertise in technical writing.
- Support team in US, Canada and ROW submissions and strategies.
- Provide regulatory review and oversight of submission documentation including deficiency responses and communications with notified bodies and other health authorities.
- Oversight of post market renewals and operations through the use of a RIMS platform; seeks opportunities for innovative approaches to meeting regulatory requirements through the use of AI.
- Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.
What We're Looking For
- Bachelor’s Degree or higher from an accredited university in a physical, chemical, biological, statistical, or engineering science or equivalent.
- Profound experience in regulatory affairs in the medical device industry.
- Direct experience authoring submissions/technical documentation.
- Direct experience managing a team of 5 or more.
- Fluent in English communication (verbal and written).
- Exceptional attention to detail as well as strong technical and non-technical communication skills.
- Must be legally authorized to work in country of employment without sponsorship for employment visa status.
Nice to Have
- Experience working in the dental device field or with dental products.
- Experience working with formulated products.
- Fluent in German language.
- Experience developing regulatory strategies, label and claims processes and project management.
- Skills include regulatory acumen, team management and development, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software.
Technical Stack
- Office Suite
- Regulatory Management Software
- RIMS platform
Team & Environment
You will be leading and developing a team of 5 or more individuals located at our Seefeld Germany plant for the Dental Solutions Business.
Work Mode
This position is remote.
All qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
