Lead Regulatory Affairs Specialist

3 weeks ago

London, Greater London, United Kingdom MSI Group Ltd Full time

MSI Group Ltd is on the lookout for an accomplished Regulatory Affairs Specialist in the medical devices sector to enhance their distinguished Consumer Healthcare division with a flexible working arrangement.

Key Responsibilities:

  • Formulate regulatory pathways for both EMEA and international markets.
  • Provide regulatory guidance to product development teams.
  • Oversee regulatory outputs, collaborating with R&D, Marketing, and regional teams.
  • Compile technical documentation and submissions for product approvals.
  • Act as the Regulatory Affairs representative within the Healthcare division.
  • Consult on product acquisitions and distributor partnerships.
  • Maintain detailed communication records with regulatory bodies and stakeholders.
  • Keep abreast of regulatory developments to ensure adherence.
  • Assist in quality audits alongside the quality assurance team.

Qualifications & Experience:

  • A Bachelor's degree or higher is required.
  • Minimum of 5 years' experience with Class I-III Medical Devices.
  • Comprehensive understanding of MDD & MDR regulations.
  • Experience in consumer health or OTC products is advantageous.
  • Familiarity with Notified Bodies is essential.
  • Fluency in English is mandatory.

We invite interested candidates to submit their resumes and cover letters detailing their relevant experience.

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