Regulatory Specialist

A long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business.

They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include:

• Provide technical support to the business, suppliers and customers on all matters relating to the safety, legality and quality of the products purchased and sold.
• A clear understanding of the legal requirements for labelling and testing within the required product areas.
• To ensure all products comply with relevant legislation.
• Produce and maintain up to date technical files for medical devices to the required standards.
• Ensure all quality and technical issues relating to technical files are resolved effectively. Escalate when necessary to the Technical Manager/Director
• Assess device related incidents/complaints for medical device reporting requirements. When required, compile and submit reportable events to relevant regulatory authorities in timely manner.
• Review of complaint and other product related information in order to create annual Post Marketing Surveillance report.
• Support the introduction of New products by advising on Regulatory requirements when appropriate.
• Perform Mock recalls as necessary.

Competencies:

• 3 years experience in Medical devices (class I and IIa).
• Experience in Technical files and Post market surveillance.
• Expert knowledge of MDR, ISO13485, UK MDR.
• Experience interacting with Notified/Approved Body.

Please share your CV at (url removed) if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.