Overview
Austin Vita are working with an exciting company at the forefront of their market who are going through an exciting growth phase. Offering a fantastic opportunity for a regulatory professional to join the team.
You'll be supporting the Regulatory Affairs department in maintaining compliance and facilitating approvals for products, ensuring they meet regulatory standards.
The Role
- Assist in the creation and review of design dossiers, technical files, and Product Approval Certificates.
- Preparation of regulatory submission for product approvals.
- Prepare the Custom Made device, Special Products paperwork along with change assessments.
- Participate in Design Control, Risk Management, Post Market Surveillance, documenting any changes.
- Ensure compliance with the Vigilance System.
- Update and review all Instructions for Use(IFU) , Packaging and Labelling
- Other duties as required by Regulatory Affairs department
Requirements
- Experience working on a class iib or class iii Medical Device
- 2-3 years experience working in a Regulatory role
- Self-driven & able to work independently
Benefits
- Flexible working - with one trip to the office a month required based in Scotland
- Achievable bonus based on company performance
- Excellent career progression
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.
