Regulatory Affairs Specialist

Regulatory Affairs Specialist II – In Vitro Diagnostics (IVD)

Assignment: 12‑Month Contract (Potential to Extend or Convert)

Pay Range: $45–$48/hour

The client is a global leader in life science research and clinical diagnostics, dedicated to advancing scientific discovery and improving healthcare outcomes worldwide. The organization develops, manufactures, and markets a broad portfolio of diagnostic products used by laboratories and clinicians across the globe.

The Regulatory Affairs Specialist II will play a key role in supporting the client’s transition to the EU In‑Vitro Diagnostic Regulation (IVDR) for products currently CE‑Marked under the IVD Directive. This role focuses on revising technical documentation, updating product labeling, coordinating regulatory notifications, and ensuring compliance with IVDR requirements. The ideal candidate will have experience in regulatory affairs or quality assurance within the IVD or medical device industry and will be comfortable working cross‑functionally in a documentation‑driven environment.

• Support the IVDR transition project by reviewing and revising assigned technical files using the latest templates and regulatory standards.
• Ensure each technical file clearly presents the product’s characteristics, performance, and evidence of conformity, incorporating current technical reports, validations, and test data.
• Complete assigned technical files within established timelines and participate in weekly team meetings to discuss progress, address issues, and provide updates to the project manager.
• Collaborate on the IVDR labeling conversion project, updating labeling specifications and tracking logs to align with monthly manufacturing schedules, product fill dates, and change requests.
• Maintain oversight of labeling conversion progress, ensuring updates are accurately reflected in product documentation and technical files.
• Support activities related to the un‑CE marking of selected products and track progress until final labeling reflects the required updates.
• Maintain technical file and labeling change tracking logs, notify regional regulatory affairs teams of changes, and coordinate with the RA SAP restriction coordinator when specific product lots need distribution restrictions.
• Perform other related regulatory and documentation support tasks as needed to ensure compliance and project success.

• Bachelor’s degree in Biochemistry, Biology, Medical Technology, or a related scientific field.
• 3–5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD or medical device industry.
• Knowledge of FDA and CE marking requirements for IVD products strongly preferred.
• Strong analytical and problem‑solving skills, with a detail‑oriented and organized approach.
• Excellent communication and interpersonal skills, including the ability to collaborate effectively across departments.
• Proficient in technical writing, data management, and computer applications relevant to regulatory documentation.
• Demonstrated ability to work independently and as part of a cross‑functional team.

Associate

Contract

Administrative

Biotechnology Research and Medical Equipment Manufacturing

• Medical insurance
• Vision insurance
• 401(k)

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