Sub Banner Default Image
Home / Jobs /

Regulatory Affairs SME - Medical Devices

Regulatory Affairs SME - Medical Devices

Back to job search

Regulatory Affairs SME - Medical Devices

Join our client's well-established Consumer Healthcare company in the Bucks/Berkshire area as a Regulatory Affairs Specialist (Medical Devices). This full-time hybrid role offers a dynamic work environment and the chance to contribute to a growing team.

Location: Hybrid - Bucks/Berkshire area
Salary/Benefits: Competitive pay, bonuses, and benefits

Key Responsibilities:

  • Develop and implement regulatory strategies for EMEA and global markets.
  • Provide guidance to product development teams.
  • Coordinate regulatory deliverables with R&D, Marketing, and local teams.
  • Prepare technical files and submissions for product certification.
  • Represent Regulatory Affairs within the Healthcare division.
  • Advise on product acquisitions and distributor agreements.
  • Maintain communication with regulators and stakeholders.
  • Stay updated on regulatory changes to ensure compliance.
  • Support audits alongside the quality assurance team.

Experience & Requirements:

  • Bachelor's degree or higher in a relevant field.
  • Minimum of 5 years in Class I-III Medical Devices.
  • Strong knowledge of MDD & MDR regulations.
  • Experience with SaMD is highly desirable.
  • Familiarity with Notified Bodies.
  • Proficiency in English is essential.

Company Culture: Work with a team that values innovation, collaboration, and professional growth.

To Apply: Please send your resume and cover letter or contact Glen Fairbrother at 02079401212