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About
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.
About
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
Nice-to-have skills
* Analytical Skills
* Sheffield, England
Work experience
* HR
* Administrative
* Healthcare
Languages
* English
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Technology, Information and Internet
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