Post-Market Clinical Affairs Specialist

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum 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.

Job Description:

 Post-Market Clinical Affairs Specialist(Solventum)

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 a  Post-Market Clinical Affairs Specialist, 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:

• Ensuring regulatory compliance across the product lifecycle by leading the planning, execution, and documentation of Post‑Market Clinical Follow‑Up (PMCF) activities in alignment with EU MDR and global regulatory requirements.
• Understands the FDA and international requirements and guidance on “Real World Evidence” and uses those concepts to generate data as applicable for US and global markets.
• Providing expertise to cross-functional partners to interpret Post‑Market Clinical activities, supporting the safe and effective use of dental products through sound evaluation.
• Supporting clinical evaluation and post‑market surveillance processes through systematic literature surveillance, post‑market data review, and integration of PMCF/Real World outputs into clinical evaluations, risk management files, and regulatory submissions.
• Developing and maintaining PMCF-related clinical documentation for new product introductions (NPI) and legacy products.

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 institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND three (3) years of experience in the medical device industry.
• Minimum of three (3) years of experience supporting Post‑Market Clinical Follow‑Up (PMCF), post‑market surveillance, and/or clinical evaluation activities in a regulated medical device industry, including development of PMCF plans, reports, and related clinical documentation in alignment with EU MDR and global requirements.

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

• Experience working in the dental device industry
• Ability to work effectively in cross-functional and cross-cultural teams.
• Strong understanding of global regulatory requirements for medical devices.
• Strong knowledge of risk management frameworks.
• Excellent communication skills, both written and verbal.
• Proven strength in clinical and medical writing.
• Ability to manage multiple complex projects simultaneously.
• Strategic thinking, critical thinking, reasoning, and interpretive skills
• Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills.

Work location: Remote – United States

Travel: May include up to 10% domestic

Relocation Assistance: Not authorized

Must be legally aut