Job Summary
We are seeking a Regulatory Affairs Specialist with direct experience in surgical sutures to manage regulatory documentation and support product compliance and market approvals. The successful candidate must have hands-on experience with the EU Medical Device Regulation (EU MDR) and CE marking.
Key Responsibilities
- Prepare, review, and maintain regulatory submissions and technical documentation for surgical sutures.
- Manage activities related to obtaining and maintaining CE marking under EU MDR.
- Coordinate with notified bodies and regulatory authorities regarding submissions, assessments, and requests for additional information.
- Review product labels, packaging, and instructions for use to ensure alignment with applicable regulatory requirements.
- Work with Quality Assurance, Production, and other relevant teams to obtain the documentation needed for regulatory submissions.
- Assess the regulatory impact of changes to products, manufacturing processes, materials, and labeling.
- Support post-market surveillance, vigilance reporting, and related regulatory documentation.
- Monitor regulatory developments and communicate required actions to the relevant teams.
- Maintain accurate regulatory records and track submission deadlines, certificates, and renewals.
- Report regulatory progress, outstanding issues, and approval timelines to the CEO and Head of Operations.
Requirements
- Direct regulatory affairs experience with surgical sutures is mandatory.
- Hands-on experience with EU MDR and CE marking is mandatory.
- Experience preparing and maintaining medical device technical documentation.
- Familiarity with medical device quality management systems, risk management, and post-market surveillance.
- Experience communicating with notified bodies and regulatory authorities.
- Strong English communication and technical writing skills.
- Excellent attention to detail, organization, and follow-up skills.
- Ability to coordinate across departments and manage regulatory deadlines.
