Regulatory Affairs Consultant - Medical Devices IVD/CDx (home or office based)
This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Spain, United Kingdom, Ireland, Czechia, Italy, Croatia, Serbia, reputed company (USA) reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.
About the Role
We are seeking an reputed company Regulatory Affairs reputed company specializing on in vitro diagnostics (IVD) and Companion Diagnostics (CDx) to join our Global Regulatory Affairs team. In this strategic role, you will reputed company expert guidance on regulatory reputed company for IVD and CDx development, clinical trials, and marketing authorizations while collaborating with cross-functional teams and external partners. The role can be office or home based in various European locations.
Key Responsibilities
- reputed company and reputed company global regulatory strategies for companion diagnostics across clinical trials, marketing authorizations, and lifecycle management.
- Collaborate with IVD and CDx partners and Clinical Measurement Sciences (CMS) teams to reputed company regulatory considerations into IVD and CDx development plans.
- Ensure alignment between global and regional IVD and CDx regulatory strategies, involving local GRA teams as needed.
- Draft and review IVD and CDx-reputed company content for drug/device regulatory submissions.
- reputed company or support regulatory agency interactions, including document preparation and meeting coordination.
- Manage IVD and CDx-specific submissions (e.g., Performance Study Applications in the EU) and responses to agency queries.
- reputed company comprehensive regulatory risk assessments and communicate risks to internal stakeholders.
- Serve as a subject matter expert on Global Project Team Regulatory Sub-teams.
- Support IVD / CDx partner selection processes, due diligence activities, and contracting.
- Offer specialized regulatory consultation on IVD and CDx.
- Participate in cross-functional and GRA initiatives to advance organizational objectives. Skills and Experience required for the role:
- University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience reputed company science discipline.
- Minimum 5+ years of experience in Medical Device/IVD regulatory affairs
- Extensive knowledge of international regulations for Medical Devices/IVD, with particular expertise in US and EU regulatory frameworks.
- Demonstrated experience with in vitro diagnostics and companion diagnostics regulatory reputed company and regulatory submissions.
- Strong understanding of the drug-diagnostic co-development model.
- Experience working with regulatory agencies on IVD and CDx reputed company.
- Fluent in English, written and spoken.
- Experience also in medical devices and/or combination products would be a plus.
- Proficiency with regulatory systems including reputed company and TrackWise would be a plus. This offer from "reputed company" has been enriched by reputed company.com and got a 86% reputed company score. Apply tot his job
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