Regulatory/Quality Assurance Manager

Are you a quality-driven professional with expertise in medical devices and regulatory compliance? A dynamic SME, dedicated to manufacturing and supplying premium disposable Class I and Class IIa medical instrumentation to NHS theatres, private clinics, and international markets. With a reputation built on quality and precision, they are seeking a Regulatory & Quality Assurance Manager to join the team.

Location: Rotheram area (Minimum one day per week in office)
Start Date: Early August 2025
Job Type: Full-Time, Mon-Fri, 9:00am - 4:30pm, compressed hours considered.

As the new Regulatory/Quality Assurance Manager, you'll oversee all regulatory and technical activities across the product range, including Class I, Class I sterile, and Class IIa medical devices. Reporting to senior management, you will play a pivotal role in driving quality standards, regulatory compliance, and operational excellence throughout the business.
Key Responsibilities
· Maintain and update the Quality Manual and Product Technical Files
· Lead Internal Audits and manage external Notified Body Audits
· Prepare Clinical Evaluation Reports and Risk Management Reports
· Oversee EtO sterilisation validation and monitoring
· Review biocompatibility testing strategies and safety documentation
· Manage the Class 7 Cleanroom
· Prepare regulatory submissions (MDR certification already achieved)

· Proven experience in regulatory and quality assurance (ideally within the medical device sector, but other highly regulated industries such as pharma, food, or lab may be considered)
· In-depth understanding of ISO 13485, MDR, and quality control processes
· Strong analytical and problem-solving skills
· Detail-oriented, highly organized, and collaborative
· Confident, professional, and comfortable working in a close-knit team environment

· Competitive salary: £48,000-£52,000
· Annual bonus (tax-free after 1 year)
· Generous holiday: 27 days + bank holidays
· Private medical insurance (after 6 months)
· 5% employee / 3% employer pension scheme
· Hybrid working (minimum once per week in office)
· Supportive, social, and high-performing culture, dog friendy offices