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