Team Consulting is an employee-owned, award-winning device design and development consultancy. We focus solely on medical devices, supporting international clients from large pharmaceutical companies to start ups. Our offices are set within our 13th Century barn in the Cambridge countryside, 5 mins from the M11.
Our clients come to us for all stages of medical device development. By combining our expertise and experience in design, engineering, human factors and regulatory compliance, we help our clients develop medical devices from early concept through to commercial launch.
As Director of QA/RA, you will be building our RA consulting capabilities, leading the strategic direction and further development of the regulatory function in our world class medical devices development consultancy, operating to ISO13485.
Why you should join our quality and regulatory team:
No two days are the same when you work in QA & RA at Team because of the hugely diverse range of device development projects that come through.
You will get to work closely with consultants on a range of activities as their trusted compliance partner. Whether it is preparing a regulatory strategy, reviewing technical documentation, helping prep for an audit, or sharing your expertise in how to apply the standards to meet client needs, you will be learning something new and know you’ve played an integral part in making amazing medical innovations.
What you will be doing:
- Grow and lead a high-performance multidisciplinary team of quality and regulatory professionals
- Provide support to global clients in developing regulatory strategies and support project teams in the creation of technical documentation for medical devices
- Enhance, apply, and profile our QA/RA expertise and capabilities with clients, such as supporting and advising clients and project teams
- Ensure a ‘fit for purpose’ QMS with clear, accessible and lean processes, procedures and ownership
- Drive a culture of adherence and need for quality to be at the heart of our services and the products we develop
- Support client and ISO audits
- Keep Team up to date with regulatory changes, best practice developments and industry trends
What we need from you:
- HNC / diploma in quality or relevant degree, e.g. in engineering or science
- Extensive experience in regulatory compliance for medical devices for US device registrations
- Experience in preparing regulatory strategies, classification of devices for US or EU markets
- Significant knowledge and experience of working within ISO 13485, FDA QSR QMS
- Extensive experience compiling technical documentation
- A track record of continuous personal development and the ability to stay current with regulatory requirements, medical industry trends and developments
- Strong influencing and communication skills
Desirable, but not essential:
- Experience in regulatory compliance for IVDs or EU device registrations
- Experience of working in a consulting environment
- Demonstrated proficiency through Regulatory Affairs Certification
- Detailed knowledge and application of ISO14971
Equal Opportunities
Team values equality, diversity and inclusion in employment and recruitment. We are committed to promoting equal opportunities and an inclusive community, where our talented people respect and value the contributions, skills, and abilities of others.
We want our people to succeed on merit, treating individuals equally, including making decisions and providing encouragement and opportunities relating to recruitment, career development and retention in a fair and consistent manner.
Our aim is a workplace free from all forms of bullying, harassment or victimisation, and unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief, and marriage and civil partnerships.