Job Description

Regulatory Affairs Coordinator

Keen to progress your regulatory affairs career in an exciting medical device company?

We are recruiting for a long-established and pioneering provider of medical device products, based in Staffordshire. You would be working within a close-knit and collaborative regulatory team within a healthily expanding company with great progression potential!

Working within the regulatory affairs team, this fast-paced opportunity gives you the chance to be a part of a growing business and to make a genuine contribution to their bright future.

This job role would suit a life sciences graduate with around 1 year+ work experience in a similar regulatory, or QA job. This position will provide you continued training but the business does require applicants to have had some initial experience in a compliance focussed role.

This job is fully site based at the company\xe2\x80\x99s state of the art facility in Staffordshire.

The position:

The key focus of this role will include;

• Coordinate and facilitate the generation of clinical data for post market activities
• Prepare reports, data trending reports and other clinical regulatory documents
• Monitor and harbour sales and surgeon relationships for clinical data and product feedback
• Maintain awareness and support colleagues regarding regulatory status` of products in relevant countries
• Prepare and review Post Market Surveillant reports, Post Market Clinical Follow up reports and review plans and data according to territory requirements.

Experience:

• Minimum 1 year+ experience working in a Regulatory/ QA/ Compliance job
• Bachelors\xe2\x80\x99 degree (or equivalent) in a relevant life sciences subject
• Work experience within the medical device or pharmaceutical industry is essential
• Brilliant communication skills and enthusiasm towards work
• Ability to speak Spanish would be an advantage, but is not essential
• Must be willing to work onsite in Staffordshire

Apply today to be considered for this opportunity!

Key Words:

Regulatory affairs, RA, documentation, post-market surveillance, post market, protocols, procedures, ISO 13485, medical device, meddev, medical technology, audit, SOP, training, progression, pharmaceutical, drug, submission, artwork, MAA, authorisation, approval, clinical.

Harris Lord