Senior Regulatory Specialist
3 weeks ago
We are looking for a seasoned Regulatory Affairs Senior Associate to support our clients in the life sciences sector.
The role:
- Collaborate with project teams to provide specialized regulatory expertise, ensuring that client expectations and interests are met.
- Utilize extensive experience in IVD/CDx development, validation, and approval to offer expert strategies and guidance to client organizations.
- Prepare regulatory submission documents, including IVDR Annex XIV applications, CTAs, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files, and Design Dossiers.
- Support the team in understanding regulatory requirements for investigational devices in the setup, management, and conduct of IVD performance studies/clinical investigations worldwide.
- Maintain our web-based clinical trial planning tool and manage information relating to global regulatory requirements for IVD devices.
- Conduct gap analyses and prepare associated reports on behalf of client companies.
- Contribute to the preparation of other regulatory documents, such as Performance Evaluation Plans/Reports and Investigator Brochures.
The estimated salary for this position is around $100,000 - $130,000 per year, depending on experience and location. We offer a range of benefits, including comprehensive health insurance and retirement plans.
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