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Medical Affairs Specialist

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Coloplast

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Location:
United States , Minneapolis

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

92936.00 - 103404.00 USD / Year
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Job Description:

This position is member of the clinical science & office of medical affairs team. This role is responsible for driving and managing clinical documentation to support marketing and regulatory needs, supporting innovation and sustaining product activities, and provide clinical expertise as required. This position will comply with regulations and ensure clinical science & OMA activities comply with global regulatory requirements.

Job Responsibility:

  • Serve as medical expert for relevant product(s) and associated clinical conditions
  • Support the required clinical input into documents including, but not limited to, instructions for use (IFUs), post-market clinical plans (PMCF), clinical evaluation reports (CERs), and other relevant documents
  • Support development and updates of Clinical Evaluation Reports (CERs) and associated documents as assigned (i.e. CER, PMCF, SSCP, PSUR, etc)
  • Develop and deliver medical device technical documents supporting product launch and sustaining activities
  • Act as clinical representative on cross-functional product development team
  • Develop and deliver relevant medical device training documents (e.g. training decks, in-service scripts, eLearning tools, etc.) supporting product launch and sustaining activities
  • Supports with relevant medical writing expertise for evidence generation (e.g. white papers, clinical studies, publication plan, etc.). Manage publication activities, as applicable
  • Develop/sustain knowledge in urology, including professional conference attendance
  • Support Investigator Initiated Study Program (IISP) as assigned
  • Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines.
  • Support to medical marketing activities (KOL engagements, symposia, review/validation of communications)
  • Participate in benefit/risk ratio assessment for vigilance and Risk Management Files
  • Coloplast employees are required to conduct business to the highest ethical and professional standards
  • comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
  • Other duties as assigned

Requirements:

  • 5+ years’ experience within clinical research and/or medical affairs activities, preferably with medical devices
  • Bachelor’s degree (health science or biotech area)
  • Advanced degree in the health sciences preferred (MS, PhD, PharmD, MD)
  • Knowledge of and experience with ISO 14155, FDA, GCP, and MDR regulations
  • Ability to travel - 10-20%
What we offer:
  • Comprehensive medical, dental, and vision insurance plans
  • company sponsored wellness programs and mental health resources
  • paid leave of absence for qualifying events
  • generous paid parental leave for both birthing and non-birthing parents
  • competitive 401(k) plan with company match that vest immediately
  • financial planning services
  • corporate discount programs for goods and services
  • generous paid time off
  • flexible work hours
  • flexible work arrangement options
  • opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
  • recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events
  • a supportive work environment
  • team-building activities, volunteer opportunities, and company-sponsored events

Additional Information:

Job Posted:
March 26, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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