- Support, prepare and coordinate regulatory submissions of multi disciplinary medical devices, including electromechanical parts, software and cloud.
- Develop regulatory strategy for submissions of new products and changes to existing products in compliance with 21 CFR Part 820, MDR and other markets’ regulations.
- Prepare and maintain technical files and general safety and performance requirements.
- Coordinate and communicate activities with external consultants and regulatory bodies.
- Review DHF documentation to assure compliance with regulatory requirements.
- Review and interpret regulatory requirements during product development and communicate to the project team.
- Review of V&V protocols and reports to assure comprehensiveness, accuracy and clarity for regulatory submissions.
- Support Risk Management activities.
- Create, update and maintain standards list.
- Support manufacturing activities.
- Provide requirements for review and approve product labelling.
- Support compliant handling.
- B.S. degree in Life Sciences or equivalent.
- 3+ years of experience in Medical Devices.
- Experience in regulatory submissions of new products.
- Excellent written and verbal communication skills, including proficiency in medical terminology from several disciplines.
- Strong multitasking ability with impeccable attention to details.
- Ability to work independently.