🚀 Senior Regulatory & Post Market Affairs Associate
📍 Selby, North Yorkshire (Hybrid)
🏢 GBUK Group
Join a growing global medical devices business and take ownership of regulatory compliance across key markets.
We’re looking for an experienced Regulatory Affairs professional to lead Post Market Surveillance (PMS) activities and support global regulatory submissions across EU, UK, US, and international markets.
🔍 Key Responsibilities:
* Lead Post Market Surveillance (PMS): PMS Plans, PSUR, PMCF documentation
* Prepare and maintain Technical Files / Technical Documentation (EU MDR)
* Support Regulatory Submissions: MHRA, FDA, GUDID, FURLS
* Ensure compliance with EU MDR, UK MDR, FDA, ISO 13485, ISO 14971
* Partner cross-functionally on New Product Development (NPD)
* Support QMS, audits, vigilance, and complaints handling
* Review labelling, packaging, and IFUs for regulatory compliance
✅ Requirements:
* Degree in Science, Medical, or Engineering discipline
* 3 years or more Regulatory Affairs experience (Medical Devices)
* Strong experience in Post Market Surveillance & Clinical Evaluation
* Proven ability with Technical Documentation / Dossiers
* Knowledge of global regulatory frameworks (EU, UK, US)
* Highly organised, detail-driven, and confident managing multiple priorities
🌟 Why GBUK?
* Global, fast-growing medical device organisation
* High-impact role with ownership and visibility
* Collaborative, supportive team culture
* Opportunity to influence patient safety and product innovation
📩 Apply now or get in touch to find out more.