Regulatory Affairs Engineer

Austin Vita is pleased to offer an exciting opportunity for a hands-on Regulatory Engineer to join our client, an innovative medical device business that designs, develops, and manufactures a range of devices for global markets based in Buckinghamshire. This will be a site-based role, suitable for someone who loves working in a team and rolling up their sleeves to tackle a broad range of tasks and challenges.

The opportunity comes at a time of site expansion and natural growth within the Quality & Regulatory department, and your responsibilities will include:

1. Working with internal departments and external regulators, suppliers, and customers to ensure ongoing product and systems compliance with applicable regulations and standards.
2. Assisting in the maintenance and review of technical product files and supporting the continued transfer to the MDR.
3. Collaborating with the design department to ensure ongoing regulatory compliance of current and new products.
4. Producing a variety of technical documentation (such as essential requirements, risk assessments, test reports, etc.) in compliance with relevant regulatory standards.
5. Working with internal departments, Competent Authorities, other national authorities, and our Notified Body on product and company registrations.
6. Collaborating with the Sales department to provide necessary documentation to support the registration of our products in international territories.
7. Assisting in the actioning of regulatory requirements associated with NCRs, customer complaints, CAPA reports, etc.

To be successful in the role, we are looking for candidates with:

1. Relevant experience with MDD/MDR (essential).
2. Experience of interpreting and implementing standards and regulations.
3. A broad background in regulatory compliance of systems and products within a QMS.
4. A broad background in electro/mechanical products is highly desirable, along with an understanding of the impact of regulatory requirements.
5. Experience of medical standards and European/FDA regulations is highly desirable.
6. Experience in medical device manufacturing and medical standards is highly desirable.
7. Familiarity with translation/localisation processes may be useful.

Qualifications:

Preferably degree educated in a technical subject, such as Engineering, or in another subject with experience in the technical industry.

You will be rewarded with a great salary and benefits, including a company bonus, so if this sounds of interest please apply ASAP.

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.