Regulatory Compliance Specialist (Home working)

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Regulatory Compliance / Quality Assurance / QARC / QA

I am working with a globally leading Medical Device organisation who are working with Real Staffing to secure a Regulatory Compliance Specialist to be based in Reading but with flexibility around home working on Monday and Fridays.

You will be working within a small team of 5 people with an incredible team ethos and a positive environment. The organisation has exciting growth plans and a large volume of New Product Introductions meaning that the Regulatory Compliance Specialist will gain experience across a diverse range of products and have excellent progressions prospects in the company.

The Regulatory Compliance Specialist will own post market activities including the preparation and execution of Field Safety Corrective Action and Field Safety Notice. You will also act as the liaison between the business and competent authorities regarding post market activities and work closely with many other business units to ensure compliance.

Key skills & Experience:

* Relevant degree or equivalent in Scientific, Engineering, Life Science field

* Previous Medical Device industry experience with in-depth knowledge of ISO 13485 and ISO 14971

* Experience with a minimum of Class II devices

* Expertise with Field Service Corrective Actions and Field Service Notice in accordance with device standards for Europe

* Working knowledge of IEC 60601 series

* Understanding of MDD & MDR

If this opportunity aligns with your career aspirations, apply now!

SThree UK and Ireland is acting as an Employment Agency in relation to this vacancy.