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Senior QA/RA Manager

Employer
Proclinical Staffing
Location
County Antrim, Northern Ireland, Belfast
Salary
Negotiable
Start date
11 Jun 2024
Closing date
25 Jun 2024

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

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.

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
GB

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