Regulatory Affairs (RA) Specialist
Healthy.io turns the smartphone camera into a clinical-grade medical device, improving access to healthcare across the globe. Our products are geared towards consumers as well as healthcare partners.
As we rapidly grow we are looking for an RA Specialist to join our RA/QA team.
The RA Specialist is responsible for assisting in planning, coordinating, and conducting clinical research projects. Ensuring compliance with research protocols, adherence to clinical objectives, and supporting the smooth operation of clinical studies. A major project is supporting the transition of the company to a new European regulation system: MDR, IVDR.
As RA Specialist you will write submissions, fill out all forms, work and Interact with product managers, production and development teams.
Role & Responsibilities
- Supporting the activities and processes required to assure that products manufactured and distributed are in compliance with all applicable regulatory requirements.
- Assisting in the planning and preparation of submissions to obtain regulatory approvals for new and modified medical devices.
- Preparation for tests, supporting engineering changes in the product/quality system.
- Prep submission including 510(K), technical files
- AMAR submissions
- Notifications of changes
- Learning new standards and training relevant staff
- Familiarity with standards and regulation
- Minimum 2 years experience in RA for medical device companies
- experience as an RA for software companies-advantage
- Academic degree in Software, Precision Sciences - Advantage
- Attention to detail and ability to manage multiple tasks
- High verbal and written skills in English