RA/Regulatory Affairs Manager, Medical Devices
Location: North London
Salary: Competitive, includes bonus and additional benefits
Our Client, a major Medical Devices company who are experiencing significant growth at this time; are looking to appoint an experienced RA Manager. This RA Manager will have exceptional people management experience and be able to support and mentor the existing team; whilst driving continued results.
Reporting to the Quality Director:
The RA is responsible for all aspects of pre and post-market regulatory compliance. This involves maintaining an awareness of regulatory requirements, advising the business on regulatory topics; supporting the NPD pipeline; ensuring market access and handling post-market regulatory issues.
- Deputise for RA/QA Director on regulatory topics
- Management Responsibilities
- Maintaining an awareness and ensure compliance with relevant regulations and laws in all markets.
- Clarify regulatory roles within projects and manage registration requests / priorities.
- Follow up and escalate issues
- Respond to enquiries from all stakeholders (including regulators; trade bodies; government bodies)
- Oversee NPD projects and progress of product registrations
- Identify and scope out new regulatory projects (timelines/ costs)
- Provide advice on quality and regulatory requirements to key stakeholders as appropriate.
- Select, monitor and manage external regulatory consultants
- Manage and support Regulatory Specialists to achieve their responsibilities and objectives.
- Overall responsibility for project progress and compliance of product areas within scope of role
- Will hold a degree in a relevant, Scientific/ technical discipline.
- Strong people management experience in a relevant RA Manager setting (Conflict resolution, coaching, staff management etc).
- Broad knowledge of regulatory requirements for medical devices including registration, manufacturing and post market controls
- Extensive experience of working with ISO13485
- Experience with Risk management (ISO14971
- The perfect person will have Microbiology / awareness of infection control too.