Job Title:
Senior Regulatory Associate (Post market)
Type of company:
Global, market leading medical devices company
Package:
Competitive salary + benefits (details available on 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 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.
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