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Quality Assurance and Regulatory Affairs Manager
2 months ago
Job Title: Quality Assurance and Regulatory Affairs Manager
Company: Jago Consultants
Location: Remote
About the RoleWe are seeking an experienced Quality Assurance and Regulatory Affairs Manager to join our team at Jago Consultants. As a key member of our organization, you will be responsible for ensuring the overall site activities are in compliance with our Quality System and applicable international standards / regulations, including ISO 13485, ISO 14971, and EU MDD/MDR requirements.
Key Responsibilities- Ensure Compliance: Partner with U.S. based Quality Managers and Quality Engineers to ensure alignment of processes and systems at the UK site, and lead CAPA related activities at the UK site in partnership with the global CAPA coordinator.
- Internal and External Audits: Lead Quality representative at the UK site for internal and external audits, including Notified Body audits, and own timely resolution of site-specific audit observations and non-conformities.
- Quality Systems and Manufacturing Quality: Partner with Quality Systems and Manufacturing Quality teams to ensure issue escalations and field safety corrective action decisions are made in a timely manner.
- Post-Market Quality: Partner with post-market quality team in the U.S. to ensure consistency in post-market process and timely closure of complaints.
- Continuous Improvement: Engage in continuous improvement activities by identifying opportunities and recommending improvements to processes across the UK site.
- Investigation and Support: Aid in investigation of complex quality issues and aid in support of potential ship holds or field corrective actions.
- Experience: Previous experience within the medical sector would be a distinct advantage, with significant experience in Quality or Regulatory related role.
- Education: Bachelor's Degree or equivalent preferred.
- Skills: Deep understanding of medical device Quality Management Systems and associated regulatory requirements required, with strong investigational and problem-solving skills, and excellent communication (verbal and written) and interpersonal skills.
- Regulatory Knowledge: Direct exposure to regulatory body inspections and/or Notified Body audits.
- Competitive Salary: Basic salary £60,000 + bonus.
- Benefits: Pension Scheme, Dental Plan.
