Medical Device Compliance Officer

2 days ago


Stockholm, Stockholm, Sweden TN Sweden Full time
Job Description Summary

TN Sweden is a leading provider of home infusion therapy for patients suffering from chronic diseases.

As a Regulatory Affairs Manager, you will play a critical role in ensuring compliance with regulatory requirements while supporting the growth and success of our company. This role will provide an exciting opportunity for you to utilize your knowledge of regulatory and marketing compliance in a dynamic environment.

Key Responsibilities:

  1. Developing Regulatory Strategies:
    • Develop and implement regulatory strategies that align with the company's goals and objectives.
    • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  2. Policy Monitoring and Implementation:
    • Monitor regulatory changes and updates to ensure compliance with applicable laws and regulations.
    • Implement policies and procedures to ensure consistency and efficiency.
  3. Cross-functional Collaboration:
    • Collaborate with internal stakeholders to ensure compliance with regulatory requirements.
  4. Communication with External Partners:
    • Serve as the primary contact for partner companies and competent authorities on regulatory matters.
    • Prepare and submit applications and reports to applicable regulatory agencies as needed.
    • Respond to requests for information from regulatory bodies.

Requirements and Qualifications:

  • MSc of Pharmacy or other relevant degree in natural sciences.
  • Minimum 2 years of experience in Regulatory Affairs.
  • 2-5 years' experience in marketing compliance.
  • Strong knowledge of regulations for medicinal products and/or medical devices.
  • Excellent communication and interpersonal skills.
  • Proven ability to lead regulatory submissions and interactions with regulatory agencies.
  • Fluent in Swedish and English.
  • Merit: Experience from both MedTech and the pharmaceutical industry.


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