Regulatory & Clinical Affairs Specialist
Experts in developing devices for minimally invasive surgery and imaging, my client in their growth phase has partnered with me to find the right fit! We are seeking a dedicated professional with grit to manage the registrations and compliance efforts for their award-winning products in the EU & US. This hybrid role demands a unique combination of managing Clinical and Regulatory evaluations.
Responsibilities
- Prepare, submit, and maintain regulatory documentation, including technical files and compliance submissions.
- Collaborate closely with R&D to manage and update technical files. Develop and implement strategies aligned with key objectives.
- Serve as the primary liaison with notified bodies, health authorities, and other key stakeholders.
- Stay informed on regulatory changes to ensure ongoing compliance.
- Foster strong communication across departments to integrate regulatory requirements into product development.
- Conduct literature reviews and clinical evaluations to support regulatory submissions.
- Background in biomedical engineering.
- 3 6 years of experience in regulatory affairs within the medical device industry (or a combination of regulatory and quality management experience).
- Strong knowledge of EU and US medical device regulations (knowledge of additional global regulations is a plus).
- Exceptional English writing skills.
