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Senior Regulatory Affairs Specialist
4 months ago
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.
- Directly manage the Regulatory Specialist, training and coaching the to assist you in delivering the key Regulatory objectives.
- Deliver key training sessions and provide proactive guidance/input across Sales, Marketing, Procurement and Project Management teams for all Regulatory updates impacting the business, products and processes.
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 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.
