A fantastic opportunity is available for a Regulatory Affairs Associate to join a thriving and expanding medical device company based in West Yorkshire.The main responsibility of this role swill be to ensure that the regulatory requirements of the company are met in line with project deadlines. Duties and Responsibilities- Update and Maintain Technical files- Oversee and assist with global product registrations in accordance with country-specific requirements and internal systems- Determine regulatory pathways for product registration in various global countries- Perform medical device regulatory compliance gap analyses and implementation.- Perform distributor evaluation and approval.- Provide Regulatory input on project teams for projects including but not limited to new product development, continuous improvement, regulatory compliance.The CandidateThe ideal candidate for this role will have a proven track record within the Medical Device sector. In depth knowledge of ISO 13485Knowledge/understanding of EU Medical Device Regulations (MDR) and MDSAP regulationsBSc (or equivalent) in a Life Science or related field.Excellent opportunities to develop are available as our client enters a period of growth. Please apply now!
Back to searchRegulatory Affairs Associate
Kenton Black Science & Engineering
Posted a month ago
Leeds, West Yorkshire LS14 1DZ
£25,000 - £35,000 per annum
Full Time
This job is no longer availableReasons could include: the employer is not accepting applications, is not actively hiring, or is reviewing applications
In order to submit this application, a Reed account will be created for you. As such, in addition to applying for this job, you will be signed up to all Reed’s services as part of the process. By submitting this application, you agree to Reed’s Terms and Conditions and acknowledge that your personal data will be transferred to Reed and processed by them in accordance with their Privacy Policy.
Explore these related job opportunities
