Senior Regulatory Affairs Specialist

TN United Kingdom; Swansea; Hybrid; GBP 40,000 - 55,000; Full time

Job summary

An award-winning medical manufacturer in South West Wales is looking for a Senior Regulatory Affairs Specialist to join their expanding team. This role offers the opportunity to shape regulatory strategies for innovative medical devices and ensure compliance with global regulations. With significant investment secured for growth, this is a chance to be part of a forward-thinking company that values expertise and collaboration. Enjoy a competitive salary, remote working options, and excellent benefits, including a pension scheme and life assurance, in a dynamic environment focused on impactful healthcare solutions.

Benefits

Pension Scheme

Sick Pay

Life Assurance

Remote Working

Qualifications

• 4-5 years of regulatory experience in medical devices.
• Strong knowledge of UKCA, CE marking, ASPAC, and LATAM markets.

Responsibilities

• Monitor changes in global regulatory requirements and their impact.
• Develop and execute regulatory strategies for medical devices.
• Prepare and submit regulatory documents (510(k), PMA, CE Mark).

Skills

Regulatory Affairs

Medical Devices

Global Regulations Knowledge

Technical File Maintenance

Education

Bachelor’s degree in Life Sciences

Master’s degree in Regulatory Affairs

Tools

ISO 13485

FDA QSR

Job description

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Senior Regulatory Affairs Specialist, Swansea

Client: Hunter Selection

Location: Swansea

Job Category: Other

EU work permit required: Yes

Job Reference:

249d11da5c3e

Job Views:

10

Posted:

28.04.2025

Expiry Date:

12.06.2025

Job Description:

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

Senior Regulatory Affairs Specialist

Location: Swansea (Remote / Hybrid)

Salary: £40,000 – £55,000 and further benefits

What is on offer?

• Salary up to £55,000
• Remote working (occasional site visits depending on location)
• Pension Scheme
• Sick Pay
• Life Assurance

An award-winning medical manufacturer in South West Wales is seeking to strengthen its Regulatory team with a Senior Regulatory Affairs Specialist. With secured investment for the next 5 years, the company is positioned for significant growth, especially after launching a new product into the market.

Senior Regulatory Affairs Specialist Role:

• Monitor changes in global regulatory requirements and communicate their impact.
• Develop and execute regulatory strategies for medical devices.
• Collaborate with cross-functional teams for timely submissions and approvals.
• Maintain and update product technical files.
• Prepare, review, and submit regulatory documents (510(k), PMA, CE Mark, international submissions).
• Work with QA to ensure compliance with standards (ISO 13485, FDA QSR, etc.).
• Coordinate and participate in audits to assess compliance.

Requirements:

• Bachelor’s degree in life sciences, engineering, regulatory affairs; Master’s preferred.
• 4-5 years of regulatory experience in medical devices.
• Strong knowledge of global regulations, including UKCA, CE marking, ASPAC, and LATAM markets.