Regulatory Affairs Specialist - Medical Devices

Walker Cole International is partnering with a leading global medical device manufacturer to appoint an Associate Regulatory Affairs Specialist. The client are based in north-west Greater London and is a hybrid position based two days a week on-site.

The Associate Regulatory Affairs Specialist will support a range of post-market regulatory activities, playing a key role in ensuring compliance, safety, and timely response to regulatory authorities and internal stakeholders across the UK and Ireland.

The key responsibilities for the Associate Regulatory Affairs Specialist will be:

• Support the preparation, execution, and follow-up of Field Safety Corrective Actions (FSCA), collaborating with Sales and the FCA Support Team to ensure timely closure of UK/Ireland field actions
• Respond to Competent Authority inquiries, including updates to internal regulatory reporting systems and documentation archives
• Provide guidance on Post-Market Surveillance activities and complaint handling processes to the commercial team, ensuring compliance with internal and regulatory requirements
• Monitor shared mailboxes, supporting customer, sales, and tender teams with regulatory documentation and timely responses
• Source, verify, and supply regulatory documentation to internal and external stakeholders
• Liaise across functions to ensure all regulatory support requests are addressed and tracked
• Participate in team training, maintain up-to-date certifications, and contribute to continuous improvement initiatives

To be a successful applicant for the Associate Regulatory Affairs Specialist role you will demonstrate the following:

• A degree in Engineering, Life Sciences, Biology, or a related discipline
• Alternatively, 3–5 years of regulatory experience within the medical device sector
• Strong computer literacy, including advanced Microsoft Excel and the ability to adapt to internal systems
• A proactive, solutions-oriented mindset with strong critical thinking and attention to detail
• Excellent organizational and administrative skills with the ability to manage tasks independently
• Clear and professional communication skills in English
• A strong focus on quality, compliance, and patient safety
• Curiosity and a genuine interest in the medical device industry

Associate Regulatory Affairs Specialist | Medical Devices | Watford | Post-Market Surveillance | FSCA | Vigilance | Field Actions | Competent Authority | Tenders | Regulatory Documentation | EU MDR | UKCA | Complaint Handling | Regulatory Operations