Regulatory Affairs Expert

7 days ago


Swansea, City and County of Swansea, United Kingdom Hunter Selection Full time
Job Description

Job Title: Senior Regulatory Affairs Specialist

Job Type: Permanent

Location: Remote / Hybrid

Job Reference: 23191/617

Salary: £40,000 - £55,000 per annum + Excellent company benefits

About the Company:

Hunter Selection Limited is a leading recruitment consultancy with a strong presence in the UK. We specialize in permanent and contract roles within various sectors, including Engineering & Manufacturing, IT & Digital, Science & Technology, and Service & Sales.

About the Role:

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our client's Regulatory team. As a key member of the team, you will be responsible for monitoring changes in global regulatory requirements and communicating their impact to the organization.

Key Responsibilities:

  • Develop and execute regulatory strategies for new and existing medical devices.
  • Collaborate with cross-functional teams to ensure timely submission of documents and approvals.
  • Maintain and update product technical files.
  • Prepare, review, and submit regulatory documents to health authorities, including 510(k), PMA, CE Mark, and international submissions.
  • Work with cross-functional teams to resolve compliance issues and deviations.
  • Coordinate and participate in internal and external audits to assess compliance with regulatory standards.

Requirements:

  • Bachelor's degree in a relevant field (e.g., life sciences, engineering, regulatory affairs). Master's degree is a plus.
  • Ideally 4 - 5 years of experience in regulatory affairs in the medical devices industry.
  • Strong knowledge of global medical device regulations, including UKCA, CE marking, and regional requirements in ASPAC and LATAM markets.

What We Offer:

  • A competitive salary of up to £55,000 per annum.
  • Remote working with occasional travel to site depending on location.
  • 25 days' holidays plus bank holidays.
  • Pension Scheme.
  • Healthcare cash plan.
  • Sick Pay.
  • Life Assurance.


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