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Advantage Technical is seeking a Regulatory Affairs Specialist for our client in Irvine, CA.
This position is Hybrid - Monday - Wednesday - Friday on-site and Tuesday - Thursday remote.
Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all our client's 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.
How You'll Make An Impact:
- Support the IVDR labeling conversion and revisions of technical files for all 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.
What You Bring:
- Requires a 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.
The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on various factors including, but not limited to, geographic location, actual experience, and job performance. This job posting is not a promise of any specific pay for any specific employee.
The range listed is just one component of the total compensation package for our employees. Based on the details of your position, we provide a variety of benefits to our employees, including medical, dental, and vision plans, pre-tax savings plans, pre-tax parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off.
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About Advantage TechnicalWith company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit .
Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.