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Regulatory Manager

4 weeks ago

Copenhagen, Copenhagen, Denmark Barrington James Full time

We are looking for a detail-oriented and experienced Regulatory Specialist to join our dynamic team in Copenhagen. This is a hybrid position, requiring 3 days in the office each week, where you will play a crucial role in navigating regulatory frameworks, specifically within the German healthcare system. The ideal candidate will have experience in medical device or pharmaceutical regulatory affairs and be well-versed in the regulatory requirements of the German market, including product registration, market access, and compliance.

Key Responsibilities:

  1. Regulatory Submissions: Prepare and submit regulatory filings to local authorities, specifically for the German healthcare system, ensuring all regulatory requirements are met for product approvals, registrations, and renewals.
  2. Compliance & Documentation: Ensure that products comply with German healthcare regulations, including maintaining up-to-date technical files, registration documentation, and regulatory compliance records for the German market.
  3. Liaison with Authorities: Act as the primary point of contact with German regulatory authorities, including BfArM (Federal Institute for Drugs and Medical Devices) and other relevant bodies, to facilitate timely approvals and market access.
  4. Market Surveillance: Stay current on regulatory updates and changes within the German healthcare system, and ensure that any changes in local regulations are communicated to the team and incorporated into compliance strategies.
  5. Regulatory Strategy: Collaborate with internal teams to develop and implement regulatory strategies tailored to the German market, ensuring that product launches and lifecycle management meet regulatory standards.
  6. Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Marketing teams to ensure alignment between regulatory requirements and product development.
  7. Risk Management: Identify regulatory risks associated with product registrations and advise on mitigation strategies for compliance gaps.
  8. Training & Support: Provide regulatory training and support to internal teams, ensuring that the regulatory framework and requirements are well understood and adhered to.

Qualifications & Experience:

  1. Education: A degree in Life Sciences, Pharmacy, Engineering, or a related field.
  2. Experience: Minimum of 3 years of experience in regulatory affairs, with a strong focus on the German healthcare system (regulations, product approvals, registrations, etc.).
  3. Market Knowledge: In-depth knowledge of German regulatory bodies such as BfArM, as well as European and international regulations (MDR, ISO 13485, etc.).
  4. Medical Devices/Pharmaceuticals: Previous experience working in medical device or pharmaceutical regulatory affairs, particularly in the context of the German market.
  5. Language Skills: Fluent in both English and German (written and verbal) to effectively communicate with German authorities and teams.
  6. Attention to Detail: Strong organizational skills and an ability to manage multiple regulatory projects simultaneously.
  7. Team-Oriented: Ability to work collaboratively within a cross-functional team environment.
  8. Problem-Solving: Ability to think critically and navigate complex regulatory challenges while maintaining a high level of compliance.
  9. Familiarity with other European regulatory bodies (e.g., EMA, CE marking, etc.) is a plus.
  10. Experience with the regulatory requirements for medical devices or pharmaceuticals in the EU.
  11. Experience working with eCTD (electronic Common Technical Document) submission systems.
  12. Knowledge of clinical trial regulations and medical device lifecycle management.
Seniority level

Associate

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing

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