1 year contract with possible extension and conversion to permanent employment

Hybrid position- 3 days on site T, TH and tbd.

• Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all products currently CE Marked under the IVD Directive.
• Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities.
• Support the IVDR labeling conversion and revisions of technical files for all Irvine products that are due to convert from the IVD Directive requirements to the new IVD Regulation.
• Work cross-functionally in weekly meetings to ensure the labeling conversion follows the plan.
• Monitor the monthly manufacturing schedule, track change requests, monitor manufacturing timelines and update the labeling tracking log to ensure accuracy of the associated product lot numbers, RA Regional notifications, RA Regional follow-ups and product restrictions, as required.
• Update previous revisions of IVDR Technical Files to the latest template and include all the necessary attachments.

Qualification:

• Bachelor's degree in biochemistry, biology, medical technology or related fields
• 3-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry.
• Knowledge of FDA, and CE marking requirements for IVD products is a plus
• Able to work independently and with others
• Communication skills, including negotiation and persuasion.
• Analytical, problem solving, computer, and critical thinking skills.
• Thorough knowledge of policies, practices and procedures related to RA.

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.

Job Type: Contract

Pay: $40.00 - $45.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Regulatory Affairs: 3 years (Required)
• In vitro diagnostics: 1 year (Required)

Ability to Relocate:

• Irvine, CA 92602: Relocate before starting work (Required)

Work Location: In person