Post-market Clinical Affairs Specialist

Solventum

Remote, United States
Base: $106,000 - $145,750; bonus/equity: variable ...
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Eu mdr and global regulatory requirements
Real world evidence concepts
Cross-functional partners
** Solventum is seeking a Post-Market Clinical Affairs Specialist who will ensure regulatory compliance and support post-market clinical activities for dental products. The role requires a strong background in the medical device industry, particularly in post-market clinical follow-up and evaluation. **

Job Summary

  • 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.
  • 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.
  • Solventum offers many programs to help you live your best life – both physically and financially.

Matching Summary

Match Score: 75

** Solventum is seeking a Post-Market Clinical Affairs Specialist who will ensure regulatory compliance and support post-market clinical activities for dental products. The role requires a strong background in the medical device industry, particularly in post-market clinical follow-up and evaluation. **

Salary

Base: $106,000 - $145,750; Bonus/Equity: variable incentive pay, if eligible; Benefits: Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits

Skills & Requirements

Must-have

  • EU MDR and global regulatory requirements
  • Real World Evidence concepts
  • cross-functional partners
  • systematic literature surveillance
  • post-market data review

Nice-to-have

  • dental device industry experience
  • cross-functional and cross-cultural teams
  • global regulatory requirements
  • risk management frameworks
  • clinical and medical writing

Key Requirements

  • Bachelor's degree or higher in scientific/technical discipline
  • 3 years of experience in medical device industry
  • 3 years supporting PMCF, post-market surveillance, or clinical evaluation

Work Rights

Must be legally authorized to work in country of employment without sponsorship

Tailored Resume

Cover Letter