Medical Affairs Specialist

Coloplast; Minneapolis (MN); On-site; USD 93,000 - 103,000; 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 clinical documentation and provide clinical expertise to support marketing and regulatory needs. The role ensures compliance with global regulatory requirements while contributing to innovation and sustaining product activities.

You will develop CERs, PMCF, SSCP, PSUR, and other documents, create technical medical device materials, and act as the clinical representative on cross-functional product teams. Travel of 10-20% is expected.

Qualifications

• 5+ years of experience in clinical research and/or medical affairs activities, preferably with medical devices.
• Knowledge of ISO 14155, FDA, GCP, and MDR regulations.
• Ability to travel 10-20%.

Responsibilities

• Serve as medical expert for relevant product(s) and associated clinical conditions.
• Support clinical input into documents such as IFUs, PMCF, and CERs.
• Develop and deliver medical device training documents (training decks, scripts, eLearning).
• Support publication activities and evidence generation.

Skills

Clinical research

Medical affairs

Regulatory compliance

Travel readiness

Education

Bachelor's degree in health sciences or biotech

Advanced degree (MS/PhD/PharmD/MD)

Job description

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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.

Major Areas of Accountability

• 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

Basic Qualifications

• 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%

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

• Health and Wellness : Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation : The compensation range for this position is $92,936 - $103,404. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world ´ s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark