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