Regulatory Affairs Associate - Medical Device

Posted 8 April by Barrington James Limited Easy Apply

Specific Responsibilities

  • Leading the preparation and submission of regulatory approvals in the markets served by the company. Including (but not limited to): EU, USA, China, Canada, Australia, New Zealand, Israel, Middle East, Korea
  • Participating in ensuring compliance with all applicable standards and regulations for company’s medical devices

Experience, Skills and Abilities

  • Strong background in regulatory affairs for medical devices, with at least 5 years of relevant experience.
  • Experience in the medical devices industry essential
  • Good knowledge and experience of EU regulations and guidance required
  • Good knowledge of ISO13485 and ISO14971 highly desirable
  • Experience of FDA 510(k) submissions highly desirable
  • Experience of regulations in Asia, Canada, Australia, Middle East desirable
  • Educated to degree level in a relevant discipline
  • Good time management, thoroughness, attention to detail and organisational skills.
  • Excellent communication skills, both verbally and in writing, using correct terminology with staff and partners at all levels.
  • Self-motivated and able to work independently, but to do so in the context of the wider team.
  • Able to understand the context of their role within the commercial objectives of the company, and have the necessary degree of pragmatism, flexibility and sense of urgency to succeed in a small company environment.

For more information contact Carlos Biggemann: 

+44(0)1293776644

Reference: 34852745

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