Our client, a global pharmaceutical organization with well-established regulatory expertise in medicinal products, is expanding its capabilities in Medical Devices (MD) and In Vitro Diagnostics (IVD). As these technologies are increasingly integrated into clinical trials and across the product lifecycle, the organization is enhancing its regulatory frameworks to address evolving global requirements, including MD/IVD-specific governance, regulatory intelligence, and process maturity.
This role offers a unique opportunity to contribute to a high-impact capability-building initiative within a dynamic and rapidly evolving regulatory environment.
Position Summary
The Medical Device & IVD Regulatory Affairs Consultant will provide specialized expertise to support the development and integration of regulatory capabilities related to medical devices, IVDs, and combination products. Reporting to the Capability Leadership Team, this role will collaborate cross-functionally with Global Regulatory Affairs, Clinical Development, Quality, and Patient Safety teams.
The consultant will play a critical role in strengthening regulatory intelligence, enhancing governance structures, improving processes, and supporting system implementation efforts, including Medical Device and Combination Product integration within Veeva Vault RIM.
Key Responsibilities
* Conduct regulatory reviews and assessments of Technical Files, dossiers, and submission packages
* Develop strategic consultation reports for Global Regulatory Submission Leads (GRSLs), Global Regulatory Leads (GRLs CMC), and regional regulatory teams
* Perform product classification determinations and borderline assessments for MD/IVD products
* Author and contribute to regulatory strategy documents for Combination Products, Companion Diagnostics (CDx), and IVDs
* Support development of Clinical Investigation and Clinical Performance Study documentation
* Manage and track CAPA (Corrective and Preventive Actions) activities and reporting
* Prepare materials for health authority interactions, including submissions to European Medicines Agency, U.S. Food and Drug Administration, National Competent Authorities (NCA), and Notified Bodies (NB)
* Develop and maintain risk management documentation in alignment with ISO 14971
* Provide input into clinical trial design to support integration of MD/IVD components
* Deliver ad hoc regulatory consultations, technical assessments, and guidance
Qualifications
* Bachelor’s degree required; advanced degree in Life Sciences, Regulatory Affairs, or related field preferred
* Proven experience in Medical Device and/or IVD regulatory affairs within the pharmaceutical, biotechnology, or medical device industry
* Strong knowledge of global regulatory frameworks, including EU MDR/IVDR and FDA regulations
* Experience supporting combination products and companion diagnostics highly preferred
* Familiarity with regulatory information management systems, particularly Veeva Vault RIM, is a plus
* Demonstrated ability to interpret and apply complex regulatory requirements
* Strong analytical, communication, and stakeholder management skills
* Experience working in cross-functional, global environments
“Skills, experience, and other compensable factors will be taken into account when determining pay rate. The pay range provided in this posting is a reflection of a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.”
General description benefit offerings disclaimer:
“W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre‑tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick me if required by law in the worked‑in state/locality.”
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