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Proclinical Staffing
Leeds, England, United Kingdom
Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position. Primary Responsibilities: This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of com
Job Source: Proclinical StaffingProclinical Staffing
Leeds
Job Description Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position. Primary Responsibilities: This role involves working closely with regulatory CMC and cross-functional teams to ensure the success
Job Source: Proclinical StaffingSurgical Innovations Ltd
Leeds
Job Description About us For over 30 years, Surgical Innovations have proudly designed, developed and manufactured high quality, precision engineered instruments for minimally invasive surgery and are a leading UK manufacturer of medical devices in its respective field. Our success is our people and we currently employ over 100 staff from our
Job Source: Surgical Innovations LtdSurgical Innovations Ltd
Leeds, England, United Kingdom
About us For over 30 years, Surgical Innovations have proudly designed, developed and manufactured high quality, precision engineered instruments for minimally invasive surgery and are a leading UK manufacturer of medical devices in its respective field. Our success is our people and we currently employ over 100 staff from our head office in Leed
Job Source: Surgical Innovations LtdX4 Group Ltd
west yorkshire
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, su
Job Source: X4 Group LtdX4 Group
United Kingdom
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, supp
Job Source: X4 GroupX4 Group Ltd
West Yorkshire
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, su
Job Source: X4 Group LtdClarity Recruiting
Leeds, England, United Kingdom
Regulatory Compliance Specialist - up to £65,000 – Hybrid West Yorkshire Overview: We are partnered with a forward thinking, market leading consultancy in the pension space. Our client are seeking a detail oriented regulatory compliance specialist to join they team on a hybrid basis in West Yorkshire. If you are seeking a role with a company you c
Job Source: Clarity RecruitingWest yorkshire, England, United Kingdom
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 [email protected] 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.
Regulatory Affairs Specialist jobs in West yorkshire, England, United Kingdom
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