Regulatory/Quality Assurance Manager

TieTalent; Sheffield; Hybrid; GBP 48,000 - 52,000; Full time

Job summary

A dynamic SME seeks a Regulatory/Quality Assurance Manager in Sheffield to manage regulatory compliance and quality activities for medical devices. This role involves leadership in quality standards and regulatory processes, with the opportunity for a hybrid work arrangement. Candidates should possess a solid background in quality assurance within regulated environments.

Benefits

Annual bonus (tax-free after 1 year)

27 days holiday plus bank holidays

Private medical insurance after 6 months

5% employee / 3% employer pension scheme

Supportive and social work environment

Qualifications

• Proven experience in regulatory and quality assurance, ideally within medical devices.
• In-depth understanding of ISO 13485 and MDR compliance.
• Mid-Senior level role suited for quality-driven professionals.

Responsibilities

• Oversee all regulatory and technical activities across product range.
• Maintain and update Quality Manual and Product Technical Files.
• Lead internal audits and manage Notified Body Audits.

Skills

Analytical Skills

Detail-oriented

Problem-solving

Organizational Skills

Team Collaboration

Education

Degree in Quality Assurance or related field

Job description

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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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