Regulatory Affairs

Summary: Seeking a Regulatory Affairs Specialist with 2-5 years of experience in the IVD industry, to provide regulatory support for product transitions from IVDD to IVDR, ensuring compliance and assisting in documentation and labeling updates. This position offers a hybrid schedule.

Job Requirements:

• Bachelor’s degree in Biology, Chemistry, Medical Technology, or related field.
• 2 to 5 years’ experience in Regulatory Affairs, or experience in QA, R&D, Manufacturing within the IVD industry.
• Strong documentation and organizational skills.
• Excellent computer application skills, including prior ERP experience and ability to perform basic statistical analysis.

Preferred Skills:

• Effective communication skills, both written and oral.

Job Responsibilities:

• Provide regulatory support for Bio-Rad products transitioning from IVDD to IVDR CE Marking.
• Collaborate with cross-functional groups to collect and coordinate information and regulatory documentation for IVDR compliant technical files.
• Update IVDR Labeling Conversion Log, ensuring documentation is prepared and processed timely to meet manufacturing schedules.
• Assist in the generation of Change Requests for product labeling according to the labeling conversion plan.
• Communicate and assist in the notification process to all International Regional Regulatory Affairs, including sending notifications, logging responses, and tracking activities to completion.
• Ensure product restrictions are implemented as required.
• Perform other IVDR or regulatory-related duties as required or assigned.

Pay Details: $29.00 to $39.00 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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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.