Job Description

Are you looking for your next senior Regulatory Affairs job opportunity?

We are recruiting for a brand new role in 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 specialist job role could suit a seasoned regulatory professional with previous experience in medical devices, post-market surveillance and clinical requirements.

This job can be hybrid remote, with minimum 3 days per week located at their Staffordshire site.

The position:

The key focus of this role is to manage and support the regulatory team with;

• customer liaison
• clinical data identification/ retrieval
• clinical requirements input for QC
• post-market surveillance management.

There will also be the responsibility to liaise with regulatory authorities and notified bodies as required and generally support the Regulatory Affairs Director in the delegation of activities.

Experience:

• Circa 5 years+ in a similar role within Medical Devices or Pharma industry.
• Strong post-market surveillance experience
• Strong experience with clinical requirements and clinical evaluation reports
• Prior managerial experience is essential
• Regulatory experience of; EU MDR & US medical device regulations as a minimum.
• Ability to speak Spanish would be an advantage, but is not essential
• Brilliant communication skills and enthusiasm towards work
• Must be willing to work onsite in Staffordshire 3 times per week

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, senior, manager, leader, lead, progression, pharmaceutical, drug, submission, artwork, MAA, authorisation, approval, clinical.

Harris Lord