Opportunity to join a driven and focused diagnostic manufacturer growing a new state-of-the-art manufacturing site. Leading the gap assessments, inputting on the regulatory strategy, and working cross functionally with the wider teams, you'll have the chance to develop your domestic and international regulatory compliance skills!
- Provide technical interface with FDA and respond to questions; establish and maintain good relationships with agency personnel.
- Coordinate, support, and author clear and concise regulatory filings and responses for both domestic and international establishment / product registrations for medical devices.
- Communicate with regulatory agencies, notified bodies, and competent authorities
- Manages the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products
- Carries out Post Market Surveillance activities such as CAPA support, post market risk management, recalls, and complaint handling
- 3 years' experience in a Regulatory environment in Medical Devices or IVDs, under and ISO:13485 / 21 CFR 820 Quality Management System
- Technical writing experience with submissions to the FDA.
- Bachelor's degree in a Life Sciences, Engineering, or related discipline
- Motivated to gain cross functional experience and understand how regulatory interacts with the larger business as a whole.
- Only US Citizens or Green Card Holders can be considered at this stage.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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