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Senior Regulatory Affairs Specialist


Minneapolis, US

Job Family:  Quality Assurance
Country/Region:  United States



Job Function Summary

  • As an individual contributor, the function of a Senior Regulatory Specialist is to lead Regulatory Strategies and submissions for product development/changes. The position is expected to apply regulatory expertise to guide cross functional team members to ensure compliance with applicable regulations

Major Areas of Accountability

  • Compile, author, and submit robust Regulatory submissions and internal Regulatory documentation, to expedite new product clearance/approval, and sustain commercial availability for all products.
  • Interact with regulatory agencies as required in a timely and appropriate manner to respond to any questions during the review process.
  • Provide Regulatory leadership to manufacturing/development teams with strategic input (including all feasible alternatives and associated risks), regulatory guidance/feedback, regulatory assessment of changes.
  • Review and approve change controls for potential impact on regulatory status.  Prepare submissions, supplements, amendments, and letters to file as needed to document rationale. 
  • Review and approve labeling, promotional literature and other documents for regulatory compliance.
  • Support post-market surveillance and assist in risk management assessment.
  • Coordinate and document recalls or other RA related field actions.  Report and update appropriate regulatory bodies (FDA and Health Canada) as needed.
  • Maintain well-organized RA records that allow ready retrieval of required information.
  • Support internal and external audits and/or due diligence activities for regulatory affairs compliance for potential partners.
  • Analyze regulatory environment changes and strategically communicate and implement new/changed requirements.
  • Provide GMP and Quality Management System, training to the applicable departments.
  • Other duties as assigned


Basic Qualifications

  • BA/BS Degree in relevant technical discipline (Engineering, Science, medically related)
  • 5+ years experience in medical device or pharmaceutical field with minimum 2+ years in Medical Device Industry
  • Experience in CE Marking, FDA and Canadian  submissions and regulations
  • Experience with OTC Drugs and Cosmetics preferred.
  • Working knowledge of Microsoft Office Suite (Word, Powerpoint, Excel)
  • Able to work well in cross-functional teams, independent yet a team player
  • Strong Oral and written communication skills, including technical writing at a professional level
  • Demonstrated ability to work in dynamic environment, work under pressure and meet due dates required.
  • Ability to interpret and implement regulation and guidance documents from regulatory bodies.
  • Analytical approach to problem solving


Preferred Qualifications

  • Advanced degree in Regulatory Sciences preferred




Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 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.


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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.


Nearest Major Market: Minneapolis

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