Medical Affairs Program Leader - Evidence & Strategy

Coloplast; Minneapolis (MN); On-site; USD 108,000 - 150,000; Full time

Benefits offered by this job

Health and Wellness

Financial Security

Work-Life Balance

Professional Development

Recognition and Rewards

Community and Culture

Competitive Compensation

Job summary

Coloplast is seeking a Medical Affairs professional to drive the clinical science agenda for Interventional Urology products in collaboration with marketing, regulatory, and the wider clinical community.

You will lead publication planning, evidence generation projects, and regulatory documentation to support product launch and sustaining activities. In this role, you will partner with internal teams and external KOLs to ensure compliant, evidence-based communications.

Qualifications

• Bachelor’s degree in health science, engineering, or biotech area required.
• 5+ years’ experience in clinical research and/or medical affairs, preferably with medical devices.
• Knowledge of ISO 14155, FDA, GCP, and MDR regulations.
• Ability to travel – 15-25% of time.

Responsibilities

• Serve as medical expert for relevant product(s) and clinical conditions.
• Oversee medical affairs strategy development and implementation.
• Provide clinical input into IFUs, PMCF, CERs, and related documents.
• Develop and update CERs, PMCF, SSCP, PSUR, and other reports.

Skills

Clinical research

Medical affairs

Regulatory knowledge

GCP

Travel readiness

Education

Bachelor’s degree in health science/engineering/biotech

Advanced degree preferred (MS/PhD/PharmD/MD)

Job description

Coloplast is seeking a Medical Affairs professional to drive the clinical science agenda for Interventional Urology products in collaboration with marketing, regulatory, and the wider clinical community.

You will lead publication planning, evidence generation projects, and regulatory documentation to support product launch and sustaining activities. In this role, you will partner with internal teams and external KOLs to ensure compliant, evidence-based communications.