A rapidly growing Medical Device Consultancy is looking for an experienced QA and RA professional to work within their specialist In-Vitro Diagnostics team. As a senior consultant within the team you will be responsible for leading client projects and supporting them with specialist QA and regulatory services to enable them to access or maintain access to markets around the world. Working directly with clients on their regulatory strategy, transition to MDD/IVDR, global submissions, fulfilling documentation, reviewing submissions, gap assessments to achieve full compliance to set deadlines. Working both independently or as part of an multidisciplined team.
- Provide consultation on regulatory standards, directives, regulations and statutory frameworks as applicable to the customer (s)
- Provide guidance on quality management systems, writing and implementing processes and carrying out training
- Carry out internal audits on behalf of clients according to ISO 13485:2016
- Write documentation including Technical Files, regulatory submissions, reports and documents as required for regulatory compliance of Customer's products
- Conduct gap assessments of client documentation against regulatory requirements such as MDR / IVDR
- Provide consultation on guidance documents published by regulators
- Plan and deliver public and in-house training courses at various locations in the UK in relation to regulatory and quality standards and issues of the industry
- Work within customer led deadlines
- Attend training to encourage multiskilled, more rounded consultants within the role
- Regular and accurate reporting to Head of IVDs on status of client projects
- Fulfilling company admin requirements
- Confident and proactive
- Organising and planning skills
- Strong communicator - multi level
- Can build relationships with clients
- Self-motivated (remote role - highly technical)
- High level of accountability
- Responsible for quality and accuracy of work
- Interpretation of regulatory requirements
- At least five years' experience within IVD/Medical Devices through positions in industry, consultancy or regulatory agencies (FDA, Notified Body etc)
- knowledge of ISO13485:2016 and experience in process implementation and giving training.
- Experience of Global registrations such as 510ks, PMA's, TGA, etc.
- Experienced lead auditor
- Hybrid working (Office/Remote) position but occasionally required to travel as and when required to head office and clients sites
- Genuine interest in regulations and client businesses
- Technical leadership and mentoring abilities
For immediate consideration please forward your most up to date CV
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.