Post-Market Clinical Affairs Specialist

SOLVENTUM

2d • $106,000 - $145,750 • Remote

About The Position

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. 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.

Requirements

• 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.
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.
• Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees