- Develop and execute regulatory strategies for new and existing medical devices.
- Ensure compliance with local, regional, and international regulations.
- Prepare and submit regulatory documents, such as pre-market notifications, technical files, design dossiers, and CE marking applications.
- Manage product registrations, renewals, and post-market surveillance reporting.
- Provide regulatory guidance to product development, quality assurance, and marketing teams.
- Review and approve labeling, advertising, and promotional materials for regulatory compliance.
- Support clinical trial teams with regulatory approvals and documentation.
At least 3-5 years of experience in regulatory affairs, preferably in the medical device industry.Bachelor’s degree in science.