Regulatory Specialist 1 or 2 (2 or 3 positions)
Company: ResearchDx, Inc.
Position: Regulatory Specialist
Location: 5 Mason, Irvine, CA 92618
Posted: May 2, 2020
Job Type: Full-time
Contact Name: Louis Ferland
Email: [email protected]
ResearchDx is the leading Contract Diagnostics Organization (CDO) to the In Vitro Diagnostics (IVD) development industry with experience in all aspects of IVD development from product design, through program, project and study design, initiation, execution, and documentation, to implementation into the CLIA laboratory environment and/or FDA submissions. We have 2 or 3 immediate openings for full-time Regulatory Specialists at the entry or more senior levels in our Clinical Research Services team.
Minimum Requirements – Regulatory Specialist (level 1 or 2 will be commensurate with experience):
- BS/MS with background or experience in biological/health sciences, especially molecular assays (e.g. qPCR, NGS, ELISA, etc.)
- Zero to 5 years of regulatory experience, especially with medical devices / IVD
- 510(k) and PMA submissions (and pre-submissions)
- GLP, GCP, GMP, ISO 13485, ISO 14971, and other relevant standards
- Product development and design control
- Clinical trial management and logistics
- Capable of great attention to details (these jobs are all in the details)
- Excellent verbal and written communication skills in English (critical)
- Resourceful, good at finding out / working things out (within guidelines)
- Must be able to work independently, after initial training
Help with the management of clinical trials, medical device development, FDA submissions, and other projects. Example tasks may include:
- Draft 510(k) and PMA pre-submissions and submissions
- Develop / draft internal regulatory processes
- Execute the regulatory aspects of design controls for product development
- Execute the regulatory aspects of analytical and clinical validation for medical devices (GxP)
- Carry out project management tasks for clinical trials and/or device development
- Draft Study Plans, Reports, and other study documentation
- Design specimen collection and shipping kits, Requisition Forms, etc.
- Draft Lab Manuals for clinical trials
- Perform sample receiving and accessioning
- Carry out Quality Control of raw and / or processed data
- Interact with sponsors, prepare electronic data transfers, etc.