Medical Device Compliance Officer

3 days ago


Solna Municipality, Sweden F. Hoffmann-La Roche Gruppe Full time
Job Description:

We are seeking a highly skilled Medical Device Compliance Officer to join our team in Sweden. As a key member of our Diagnostics function, you will be responsible for ensuring compliance with applicable laws, regulations, and standards.

Key Responsibilities:

  • Develop and implement the company's legal and compliance strategy and priorities in alignment with business objectives.
  • Maintain Roche's license to operate by ensuring alignment with legal and regulatory requirements.
  • Partner with the business in tender processes, identifying and analyzing opportunities and mitigating legal risks.
  • Advising on new aspects of the law, ensuring continuous compliance with changing business models and digitalization.
  • Managing corporate law matters, including board of directors meetings, appointment of directors, and delegations of authorities.
  • Act as the single point of contact for all compliance and legal matters, coordinating actions with external counsels while ensuring quality and containing costs.
  • Ensuring execution of local compliance initiatives, including training, processes policies, and standard operating procedures.
  • Timely handling of all compliance issues that represent a material compliance or reputation risk.

Requirements:

  • Law degree from a reputable University.
  • Qualified lawyer in Sweden.
  • A minimum of 5 years experience, obtained via a combination of private practice and in-house, preferably in the medical device, biotech, or pharmaceutical industries.
  • Proven track record of managing complex legal and compliance issues.
  • In-depth knowledge of healthcare laws, regulations, and compliance standards in Sweden.
  • Deep understanding of the Nordics market and culture.
  • High level of integrity, professionalism, and ethical standards.
  • Fluent in written and oral English and Swedish.


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