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