We are working with a fast-growing medical device company who are increasingly recognised for their specialist products and educational services within their specialist niche.
We are partnering with them to find an Exceptional RAQA Professional to spearhead an exciting new phase of development as they consolidate their position here in the UK and Europe and take on new markets such as the USA.
This is a fantastic opportunity to join at a time of growth and new product development- to shape a department with autonomy to influence and implement your own strategy working closely with the Director.
Job Title: QARA Manager
Benefits: Comprehensive benefits including
- Managing the alignment of the company's business needs to regulatory, legislative developments.
- To manage and lead a team of 4 QA&RA staff in creating, implementing and maintaining the quality management system in accordance with the company strategy, policy and regulatory requirements
- Accountable for product and regulatory compliance across all products and supporting documentation.
- Must have expertise and proven track record in Regulatory Affairs management covering the Medical Device Directive 93/42EEC and FDA, TGA.
- Must be experienced manager and leader, able to demonstrate excellent communication and interpersonal skills.
- Managing supplier quality assurance, supplier technical agreements.
- Manage audit schedule, conduct audits or write audit reports and close out CAPA.
- 510K extremely desirable.
To find out more information please apply with your CV Now or contact James Powell- 02038000509
Projectus Consulting are a leading Medical Device Recruitment Consultancy. We're a niche business who provide a highly specialist service to both employers and candidates in the Medical Technology Sector.
We are dedicated to finding the right opportunity for you.