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Regulatory Affairs Expert
2 months ago
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.
