Regulatory Affairs Specialist

Title: Regulatory Affairs Specialist

Location: Based at Head Office in Buckinghamshire

Therapy Area: Stoma & Wound Care

Salary: Highly competitive salary + exceptional benefits on offer

Evolve Consultant: Andy Boyd

Ref: 7383

A fantastic new opportunity to join a market-leading Medical Device organisation within the Stoma and Wound Care market.

Key roles and responsibilities for the Regulatory Affairs Specialist

* Ensure timely product release to maintain continuity in the supply chain (sterile/non-sterile medical devices and one medicine)

* Ensure Good Distribution Practice is followed in relation to relevant processes (release, returns, storage, transport, logistics, vigilance).

* Be the Person Responsible for GDP and for Regulatory Compliance in line with Article 15 of the Medical Devices Regulation.

* Be the Management Representative in respect of ISO13485.

* Lead on training related to Regulatory requirements to all levels of staff within the business.

* Assist with investigating and managing customer complaints and to respond to technical enquiries relating to our products with assistance from third parties.

Minimum requirements for the Regulatory Affairs Specialist

* Educated to degree in Life Sciences, Pharmaceuticals, Engineering or related subject.

* Proven Regulatory experience from Medical Devices/Pharmaceutical field.

* Ability to demonstrate Regulatory knowledge (MDD) in Class I and Class IIa devices as a minimum.

* Hands on experience of creating and maintaining technical files in accordance to MDD/MDR.

* Experience of working with ISO 13485 and ISO 14971.

* Experience of dealing directly with Notified Bodies and Competent Authorities such as MHRA.

Recruitment Process

2 stage process:

1st stage - Face to face Interview

2nd stage - Assessment centre

If you want to hear more about this role, please send us your CV by clicking 'apply now