The role is focused on creating and maintaining technical file, design dossiers and PMA submission.
The candidate will have a good science degree with experience of working in the medical device industry, preferably in a regulatory or QA role
- Compile and submit regulatory submissions for approval to regulatory authorities worldwide.
- Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices regulations.
- Compile and maintain Technical Files, Design Dossiers, PMA and 510(k) files.
- Supporting and advising other functions within the business for information requests, drug tariff applications, review of agreement, artwork and literature review.
- Provide regulatory input to new product developments and major extensions to existing product lines.
- Support customer market registration activity, within the terms of existing contractual obligations.
- Responsible for regulatory review and approval of key compliance records (e.g. Labelling and Instructions for use) for all sites.
- Support Technical File and Design Dossier audits/reviews by Notified Bodies, competent authorities or customers.
- Participate in company quality system audits.
- The successful candidates will have at least 2:1 degree in Physics, Chemical Engineering or related subjects with experience in healthcare device development industries.
- The candidate will have excellent communication skills both written and verbally with employees, customers and suppliers.
Skills: Good knowledge of MDR, ISO 13485, experience with 510(k) applications, Science based degree, Regulatory Affairs/QA
All applicants must be eligible to live and work in the UK.
You must have the right to work in the UK. Learn more
- Agency: ST Recruitment
- Contact: Sam
- Phone: 01737241823
- Reference: BTO16
Website: ST Recruitment
- Posted: 23rd September 2022
- Expires: 21st October 2022