Austin Vita has been engaged by a family-owned business who supply directly into the Medical Devices Industry. We have been tasked with finding the newest addition to the team, a Quality Assurance and Regulatory Affairs Manager.
Whilst supporting the business through a time of change and growth and providing QARA expertise to all departments, you will be a hands-on manager with 10+ reports which will provide you with an excellent opportunity to learn skills across the entire product lifecycle.
Working across the product lifecycle for new and existing developments (Classes I-III), responsibilities will include –
Preparing and collating technical documentation for CE and FDA review.
Managing Notified Body relationships and interactions with other regulatory/government bodies
Transitioning to the EU medical device regulation (MDR 2017/745)
Promote audit readiness, preparing quality teams for audits by external bodies and facilitating audits as needed.
Reviewing customer feedback, investigation and reporting incidents.
Defining key business processes and systems of control to assure product integrity.
Ensuring the definition and identification of personnel involved in product release.
Promoting awareness of and working with employees, consultants, customers, sub-contractors and suppliers to assure quality and regulatory compliance.
To succeed in this role and company you will need to have a hands-on and strategic mindset, able to switch between the two dependent on context. You will also be required to have at least 5 years of QA or RA experience within the Medical Devices industry with knowledge of the other. Any people/project management skills will only help your application.
If you feel that this role is something you’d be interested, please apply below and I will endeavour to get in contact with you.
QARA Manager – £45,000 to £50,000 – Nottingham
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.