Location: Fremont, California (On-site preferred; remote option available for strong candidates)
Division: Regulatory and Clinical Affairs
Overview: This role is part of the Regulatory and Clinical Affairs team, responsible for ensuring that our in vitro diagnostics development meets all applicable regulatory requirements both domestically and internationally.
Key Responsibilities:
Documentation: Draft Post Market Performance Follow-Up Plans and Reports for Toxicology, Therapeutic Drug Monitoring Assays, and Clinical Chemistry Controls.
Change Orders: Process change orders for approval of clinical documentation within the electronic records management system.
Clinical Documents: Assist in preparing additional clinical documents as needed, including Clinical Performance Reports and Summary of Safety and Performance Reports.
Regulatory Compliance: Organize, update, and maintain regulatory documentation according to department and company procedures, including maintaining logs and trackers.
Collaboration: Maintain positive and collaborative communication with Quality, Regulatory, and Research and Development teams.
Miscellaneous: Perform other related duties and responsibilities as assigned.
Keys to Success:
Education: Bachelor's degree in Biological Sciences or related field preferred.
Regulatory Knowledge: Experience with EU IVD regulation (IVDR) is a plus.
Technical Writing: Ability to write clear, understandable technical documentation.
Attention to Detail: Strong attention to detail and ability to manage multiple tasks and deadlines effectively.
Organizational Skills: Excellent organizational skills and capability to handle multiple assignments simultaneously.
Additional Information: Preference for candidates able to work on-site at the Fremont, California facility, but a remote option is available for exceptionally qualified candidates.
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