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Senior QA/RA Manager

2 months ago

Belfast, United Kingdom Proclinical Staffing Full time

Proclinical is seeking a dedicated Senior Manager for Regulatory Affairs & Quality Assurance. This role involves leading a team of regulatory and quality professionals The successful candidate will be responsible for monitoring and interpreting evolving regulations, developing organizational strategies, and ensuring product development meets regulatory requirements and customer quality expectations.

Responsibilities:
- Lead a team of regulatory and quality professionals to support a class III product portfolio.
- Monitor, interpret, and apply governmental regulations, agency guidelines, and internal procedures to assure compliance.
- Develop strategies, processes, goals, and metrics to improve regulatory and quality processes.
- Serve as the PRRC with overall responsibility for device conformity, technical documentation maintenance, and post-market obligations.
- Direct all regulatory activities to ensure product development and sustainment meet regulatory requirements and customer quality expectations.
- Collaborate with various departments to ensure corporate goals and strategies are met.
- Represent regulatory and quality processes during internal and external audits.
- Recruit, select, and onboard top talent and maintain a high level of team engagement.

Key Skills and Requirements:
- Level 6 qualification in a science, engineering, or related field. Advanced degree preferred.
- RAC certification desired.
- Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.
- Technical knowledge of medical device product lines.
- Experience with trending and analysis.

If you are having difficulty in applying or if you have any questions, please contact Jaeme Pawl at j.pawl@proclinical.comosh Thomspon on j.thompson@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.