Medical Affairs Program Manager

About the role

The Medical Affairs Program Manager joins the Clinical Science & Office of Medical Affairs team to drive clinical documentation, support innovation, and ensure regulatory compliance for Coloplast products.

Key responsibilities

• Generate clinical evidence to support product claims and engage researchers through grants and evidence‑generation activities.
• Develop and maintain clinical evaluation reports, post‑market clinical plans, and other regulatory documentation.
• Lead medical affairs strategy, oversee medical writing, manage publications, and support medical marketing activities.
• Facilitate advisory boards, KOL engagements, and investigator‑initiated studies while ensuring timelines and milestones are met.

Required profile

• Bachelor’s degree in health science, engineering or biotech; advanced degree preferred.
• 5+ years of experience in clinical research or medical affairs, preferably with medical devices.
• Knowledge of ISO 14155, FDA, GCP and MDR regulations.
• Ability to travel 15‑25%.

Required skills

• Proficiency with Microsoft Word, Excel and PowerPoint.
• Experience reviewing and interpreting scientific data and translating it for cross‑functional use.
• Strong project management and organizational abilities.

What we offer

• Comprehensive health, dental and vision insurance.
• Competitive 401(k) plan with immediate vesting company match.
• Generous paid time off, flexible work arrangements and parental leave.
• Professional development programs, tuition reimbursement and mentorship.
• Salary range $108,000 – $150,000 per year.