We are seeking an experienced Regulatory Affairs professional to support global regulatory initiatives across medical device and in vitro diagnostic portfolios. This role will provide strategic and operational regulatory expertise spanning product development, submission planning, compliance oversight, and health authority engagement.
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The ideal candidate brings a strong understanding of international regulatory frameworks and experience advising cross‑functional stakeholders in complex, highly regulated environments.
Key Responsibilities
Conduct comprehensive evaluations of regulatory documentation, including product technical documentation, registration dossiers, and submission packages to ensure alignment with applicable regional requirements.
Develop strategic regulatory advisory reports to support global and regional regulatory leads, including chemistry, manufacturing, and controls (CMC) considerations where applicable.
Perform regulatory pathway analysis, including product categorization assessments and determinations for products that may fall into complex or multi‑regulatory frameworks.
Author and contribute to regulatory strategy documentation for products that may involve drug‑device combinations, companion diagnostics, and standalone diagnostic platforms.
Support preparation and review of documentation related to clinical investigations and clinical performance evaluations, ensuring regulatory compliance and submission readiness.
Provide oversight and tracking support for quality system corrective and preventive actions, including documentation review and status reporting.
Prepare briefing materials and response strategies for interactions with regulatory authorities and conformity assessment bodies in global markets.
Contribute to risk management activities in accordance with recognized international standards for medical devices, ensuring appropriate documentation and traceability.
Offer regulatory input into clinical and performance study design considerations to support integrated device and diagnostic development programs.
Deliver technical regulatory assessments and advisory responses to emerging or ad‑hoc regulatory inquiries.
Qualifications
Bachelor’s degree in life sciences, engineering, regulatory affairs, or a related discipline (advanced degree preferred).
Demonstrated experience in regulatory affairs within medical devices and/or in vitro diagnostics.
Strong working knowledge of global regulatory frameworks (e.g., U.S., EU, and other major markets).
Experience supporting complex or combination product regulatory strategies preferred.
Familiarity with quality management systems and risk management principles.
Excellent analytical, documentation, and stakeholder communication skills.
Ability to operate both strategically and tactically in fast‑paced, cross‑functional environments.
Preferred Experience
Prior experience engaging with global health authorities.
Exposure to multi‑jurisdictional regulatory submissions.
Experience supporting clinical study regulatory documentation.
“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 hourly rate; other employment options may be available that may result in pay outside of the provided range. xpzdshu ”
“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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