Senior Regulatory Affairs Associate

Job Title:

Senior Regulatory Associate (Post market)

Type of company:

Global, market leading medical devices company

Package:

Competitive salary + benefits (details available on application)

All potential candidates should read through the following details of this job with care before making an application.

Everything you need to know about the role:

This is a key position within a Regulatory Affairs team, supporting post market surveillance activities, technical documentation, and global regulatory compliance. You’ll work closely with cross-functional teams and senior leadership, contributing to both ongoing product compliance and new product development. The role offers a broad scope across EU MDR, UK regulations, and international markets, with involvement in audits, submissions, and regulatory strategy.

You will:

• Prepare, maintain, and schedule post market surveillance documentation, including PMS plans and reports
• Support post market clinical follow-up activities and documentation
• Contribute to technical documentation and regulatory dossier preparation for EU MDR and other global markets
• Liaise with internal teams to ensure regulatory compliance across product lifecycle activities
• Assist with regulatory submissions, registrations, and maintenance of approvals
• Support internal and external audits, including QMS activities
• Provide regulatory input into new product development projects
• Maintain regulatory databases (e.g. MHRA, FDA, GUDID)
• Review and approve packaging, labelling, and product literature
• Support vigilance, complaints handling, and post market activities alongside Quality teams

Experience and qualities that make you a strong fit:

• Solid experience within the medical device industry
• Strong background in post market surveillance and documentation
• Experience preparing or maintaining technical dossiers
• Good understanding of MDR, MDD, UK MDR, IVDR/IVDD and relevant ISO standards
• Strong organisational skills with the ability to manage multiple priorities

Preferred:

• Experience with post market clinical xwzovoh follow-up (PMCF)
• Exposure to internal and external audits
• Knowledge of clinical evaluation and risk management (ISO 14971)

What’s on offer:

• Opportunity to work in a collaborative, growing regulatory team
• Exposure to global regulatory frameworks and submissions
• Involvement in both lifecycle management and new product development
• A varied role with strong cross-functional interaction

Could this be the role for you?

If you’re looking to take the next step in your regulatory career within a dynamic medical device environment, this could be a great opportunity to broaden your experience and make a real impact.