Senior Regulatory Affairs Associate in UK

Location: Not Specified
Salary: £45,000 per year
Recruiter: Kenton Black
Job Hours: Unknown

Do you have experience of working in the Medical Device Industry?

Do you have experience of working in Regulatory Affairs?

Are you looking to develop your career?

If so, this could be the opportunity for you!

I am working in partnership with a leading manufacturer of medical devices they specialize in innovation of new products, using their unique technology platform.

This year, they have had a delivered a strong first half performance, increasing sales of their products globally.

A vacancy has now arisen for a Regulatory Affairs Associate to join their team.

The Role: Compile, review and maintain regulatory submissions, Technical Files, and labelling for completeness and quality.

Maintain and update dossiers for existing Marketing Authorizations.

Identify regulatory requirements for new product and changes to existing products.

Determine the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies.

Contribute within new product development projects to ensure compliance with internal product commercialization process and global regulations.

Review and approve product labelling/marketing materials for compliance with applicable regulations and standards.

Review new and existing EMEA regulations, guidance documents and standards, and prepare comments based on impact to product and business.

Support post-market surveillance and vigilance activities, including submitting reports to authorities.

The Candidate: Degree, or equivalent qualification, in a Life Science.

A strong working knowledge of Medical Device regulatory affairs environment including but not exclusive to:?

Regulations, Submissions and Technical Files.

Experience of communicating with Regulatory Authorities and Distributors?

Experience in clinical trials, specifically regulatory activities, and submissions for the trials Experience in regulatory audits, ISO certification, GMP requirements and document control.


About Kenton Black


Kenton Black Group are nationwide recruitment specialists across multiple sectors, servicing the Construction, Finance, Science & Engineering, International and Corporate Services markets across the UK and overseas. We are passionate about building careers, offering a long-standing and trusted brand with significant industry expertise gained over 15 years. We are, the people, people.

We provide our clients with the world’s best talent who are both actively and passively searching for opportunities, with a level of diligence and expertise that far outmatches our competitors’ and we endeavour to ensure that our clients make the most informed acquisitions possible.

Our team is made up of an incredibly diverse group of people demonstrating that we leave no stone unturned to find the best person for each and every job we have to offer. Our business is built on honesty, integrity, and every one of our staff is expected to reflect these values in every aspect of their work.

For the past 5 years, Kenton Black Group has been proud to be the only supplier to employ an in-house EDI team. Boasting an in-depth knowledge of equality legislation within the recruitment industry, including ex-offender & ex-forces. Experience in putting in place initiatives to drive balance and a proven track record in being able to work strategically to deliver a service that supports the achievement of organisational objectives with experience in multi-site, working in both the private and public sectors in the UK and globally.

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