Job Ref: 215992688

Date: 2022-03-08 16:12:48

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Location: Aylesbury

Industry: Medical Devices

Job Title: Regulatory Affairs Engineer

Salary: £40,000 to £48,000

We are a market leading Medical Device company and due to continued growth, we have an exciting opportunity available for a Regulatory Affairs Engineer to join our team in Aylesbury.

As our new Regulatory Affairs Engineer, you will be responsible for the maintenance and development of our technical files and will assist in the transition to MDR. You will be involved in Post Market Surveillance, Customer Complaints and CAPA reporting.

RESPONSIBILITIES

Work with internal departments and external regulators, suppliers and customers with a broad remit to ensure the ongoing product and systems compliance to the applicable regulations and standards.

Assist in the maintenance and review of technical product files and assist in the continued transfer to the MDR.

Work with the design department to ensure ongoing regulatory compliance of current and new products.

Collaborate with a team of design engineers to produce a variety of technical documentation (such as risk assessments, test reports, etc).

Produce documentation in compliance with the relevant regulatory standards.

Work with internal departments, Competent Authorities, other national authorities and our Notified Body on product and company registrations.

Author, proofread liaise with translators and publish user manuals for a variety of products.

Assist in the actioning, monitoring and reviewing of NCRs, customer complaints, CAPA reports and return in warranty failures, assisting with the identification and implementation of corrective / preventative actions to continuously improve on these.

EXPERIENCE

Proven Regulatory Affairs Experience within the Medical Device sector.

Experience of interpreting and implementing standards and regulations essential.

Broad background in quality and regulatory compliance of systems and products essential.

Broad background in electro/mechanical products essential, along with an understanding of the impact of regulatory requirements.

Experience of medical standards and European/ FDA regulations such as ISO 13485, EC 93/42 and MDR highly desirable.

Experience of medical device manufacturing and medical standards desirable.

If you have the necessary skills and experience and want to join a company passionate about your progression, click apply now or call (phone number removed) and ask for Kris Holmes

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