Company Overview
BPR Medical Limited is an international leader in the design and manufacture of medical gas therapy solutions. Every day BPR ‘s gas therapy products are used in hospitals and homes to save and improve the lives of thousands of people. From supporting newborn babies to making life more comfortable for the elderly with respiratory distress, our products are trusted to deliver time and time again. BPR’s reputation and the reputation of our customers depend on the reliability of our products, so when it comes to design and manufacture we are proud perfectionists – focusing on user-centred design, rigorous production standards and stringent quality tests. BPR are passionate about improving patient care throughout the world and we look forward to working with you to achieve this.
About the Role
We’re seeking an experienced Regulatory Affairs Manager to join our innovative medical device company at an exciting time of growth. This is a hands-on role reporting directly to the Managing Director, where you’ll take ownership of regulatory compliance and product marketing authorizations across our portfolio. We operate in Europe and all major MDSAP jurisdictions including the US, Australia, Brazil, Canada, and Japan.
Key Responsibilities
- Lead regulatory affairs activities, ensuring compliance with UK and EU MDR and other international regulations
- Serve as the Person Responsible for Regulatory Compliance (PRRC) under EU MDR requirements
- Manage technical file preparation and maintenance for notified body submissions
- Ensure timely completion of regulatory documentation and submissions to meet critical deadlines
- Oversee and coordinate internal audit processes
- Provide strategic regulatory guidance to cross-functional teams
- Act as the QMS Management Representative
Essential Requirements
- At least 5 years of hands-on regulatory affairs experience within medical devices (minimum Class IIa products)
- Proven track record of working with notified bodies and maintaining technical documentation
- Strong understanding of EU MDR requirements and regulatory frameworks
- Demonstrated ability to work effectively to deadlines and deliver results
- Excellent communication skills with ability to influence and coordinate across departments
What We Offer
- Direct reporting line to Managing Director with high-level visibility and impact
- Hybrid working arrangement with flexibility
- Competitive salary package (including life assurance and health plan)
- Opportunity to work with innovative medical device technologies that are making a real difference in healthcare safety
- Family-oriented culture with strong focus on work-life balance
APPLY