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Senior Regulatory Affairs Specialist
2 months ago
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Senior Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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South Yorkshire, United Kingdom Austin Vita Full timeJob DescriptionAustin Vita is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Quality and Regulatory Affairs department, you will play a critical role in ensuring the company's medical devices comply with national and international legislation.Key Responsibilities:Regulatory Compliance: Manage regulatory...
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. Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. 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.
- 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.
