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.
Requirements
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.
