Job Description
Job Overview
We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to join our team, with at least 2 years’ experience in Medical Device Regulatory Affairs, Post Market Surveillance, Quality Assurance or Design Control or related function. In this role, you will be responsible for ensuring that our products comply with all regulatory requirements and standards. You will play a crucial part in the development and maintenance of regulatory submissions, working closely with various departments to facilitate compliance and quality assurance throughout the product lifecycle.
Please not there is a requirement to be in the office 3 days per week in Crewe, Cheshire.
Responsibilities
1. Prepare and submit regulatory documents to relevant authorities in accordance with established guidelines.
2. Review product labels, promotional materials, and technical documentation for compliance with regulatory standards.
3. Liaise with internal teams, including Quality Assurance and Research & Development, to ensure that all aspects of product development meet regulatory requirements.
4. Monitor changes in regulations and assess their impact on existing products and processes.
5. Conduct audits of documentation and processes to ensure compliance with internal ...