Associate Director, Regulatory Affairs

**3M Health Care is now Solventum**

**At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.**

**We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.**

**The Impact You’ll Make in this Role**

As an **Associate Director, Regulatory Affairs (M/F/x)**,**you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

- _ Leading and developing a team of individuals located at our Seefeld Germany plant, for the Dental Solutions Business_
- _ Providing expertise in developing EU MDR compliant technical documentation, including expertise in technical writing_
- _ Support team in US, Canada and ROW submissions and strategies_
- _ Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality in addition to excellent organizational, prioritization, oral and written communication skills_
- _ Providing regulatory review and oversight of submission documentation including deficiency responses and communications with notified bodies and other health authorities as applicable_
- _ 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 and with multiple government and non-government organizations having an impact on market access and distribution._

**Your Skills and Expertise**
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

- _ 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 s_trong technical and non-technical communication skills_

Additional qualifications that could help you succeed even further in this role include:

- _ 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_

**Work location**:Remote

**Travel**:May include up to 25% domestic/international

**Must be legally authorized to work in country of employment without sponsorship for employment visa status.**

**Supporting Your Well-being**

Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

**Diversity & Inclusion**

(*) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

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