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Regulatory Affairs Specialist - Medical Devices (Maternity Cover)
Location - Basingstoke
Salary - 35,000 - 45,000 (depending on experience)
Fixed-term contract until 31st March 2026
We're recruiting on behalf of our client for a Regulatory Affairs Specialist to join their team in Basingstoke. This is a maternity cover contract until March 2026, supporting the Regulatory Affairs function for their medical device portfolio.
This role will suit someone with experience in regulatory affairs for medical devices or IVDs who enjoys working across different teams and supporting products through their full life cycle.
What you'll be doing:
- Reviewing and maintaining regulatory submissions, technical files and labelling.
- Managing change requests and assessing the impact on licences.
- Supporting Operations, Sourcing and Purchasing teams with engineering change activities.
- Responding to customer and commercial enquiries about product classification and regulatory status.
- Helping to acquire and maintain pre- and post-market licences globally.
- Building relationships with regulatory agencies and commercial partners.
- Supporting audits and ensuring audit readiness.
- Keeping trackers up to date and reporting on project progress.
- Staying on top of changes in regulatory requirements, particularly in IVD and international markets.
What we're looking for:
- Previous experience in Regulatory Affairs, ideally within medical devices or IVD.
- Strong written and verbal communication skills.
- Attention to detail with good problem-solving skills.
- Able to manage multiple priorities and work in a global, cross-functional team.
- Proficient with systems such as SAP, MasterControl and Microsoft Office.
- A proactive, flexible approach with the ability to work independently.
Why apply?
- Competitive salary (35,000 - 45,000 DOE).
- Fixed-term contract until March 2026 - perfect for someone looking for a secure contract role.
- Opportunity to work with a global organisation and gain exposure across multiple markets.
- Join a collaborative, supportive team environment.
If you're interested, please apply or get in touch for a conversation.
