Regulatory Affairs Specialist II
Job Posting Summary : Seeking a Regulatory Affairs Specialist to manage updates and compliance for technical files and labeling under the new IVDR requirements, ensuring seamless transition from IVD Directive.
Job Requirements :
Bachelor's degree in biochemistry, biology, medical technology, or related fields.
3-5 years of experience in Regulatory Affairs (RA), Quality Assurance (QA), Research and Development (R&D), Manufacturing, or Project Management within the In Vitro Diagnostic (IVD) industry.
Familiarity with CE Marking and IVDR Technical Files.
Experience with change requests for product labeling.
Preferred Skills :
Knowledge of FDA and CE marking requirements for IVD products.
Job Responsibilities :
Support the transition of Bio-Rad products from IVD Directive requirements to the new In Vitro Diagnostic Regulation (IVDR).
Update labeling to comply with IVDR requirements and revise technical files as necessary.
Work cross-functionally to ensure labeling conversion aligns with planned timelines.
Monitor manufacturing schedules, track change requests, and ensure accuracy in labeling tracking logs.
Update previous revisions of IVDR Technical Files to the latest template with all necessary attachments.
Track RA Regional notifications and follow-ups, and monitor product restrictions as required.
Pay : 25-35
Pay Details : $25.00 to $35.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan.
Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs.
In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer / Veterans / Disabled
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