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Company Information:
Join a well-established, family-owned business specializing in innovative home-use medical devices aimed at improving circulation and comfort. Operating globally, the company prides itself on a collaborative, easy-going culture with a highly educated workforce and a cash-strong financial position!
Role Overview:
Our client are seeking an experienced Quality Assurance & Regulatory Affairs Manager to join theirgrowing team. This pivotal role supports product registrations, document maintenance, and compliance activities, helping to manage a small team within the department. The successful candidate will be key in driving quality and regulatory projects, including the transition to new medical device regulations and integrating innovative technology solutions.
Key Responsibilities:
- Manage product registrations and maintain regulatory documentation
- Lead regulatory compliance including MDR, FDA, CAPA, QMS, and change control processes
- Oversee audits and risk management activities
- Support and manage a small team within the department
- Collaborate closely with commercial and cross-functional teams
Person Specification:
- Proven experience in medical devices QA and regulatory affairs
- Strong knowledge of MDR, EU and FDA regulations, and product registration processes
- Experience with project management and people management
- Familiarity with auditing, CAPA, QMS, and risk management
- Ability to commute to office location near Bracknell (hybrid working model)
- Career longevity and commitment to the medical devices industry
- Immediate start preferred
Package:
- Competitive salary up to 55k, with pension after probation
- 25 days annual leave plus public holidays
- Hybrid working arrangement (3 days in-office)
- Supportive and social work environment with free parking and excellent local amenities
- Flexible and easy-going culture
