New

Regulatory Affairs Specialist

Advantage Technical
$50.00-$50.00
paid time off, paid holidays
United States, California, Irvine
Oct 07, 2025
Regulatory Affairs Specialist - IVDR Transition Join our clients mission to bring quality diagnostics to labs around the world. As a Regulatory Affairs Specialist, you'll play a vital role in supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition-ensuring company's CE-marked products continue to meet the highest global standards of safety, quality, and compliance. This is an exciting opportunity for someone who enjoys working at the intersection of science, regulation, and innovation, and who takes pride in building the documentation and structure that make regulatory excellence possible. How You'll Make an Impact Support the IVDR transition for all CE-marked products by preparing and revising technical files to the latest standards. Generate comprehensive technical files that clearly present product characteristics, performance data, and evidence of conformity using the most recent templates and documentation requirements. Collaborate cross-functionally with Quality, R&D, Manufacturing, and Regulatory teams to ensure all documentation is accurate, complete, and delivered within defined timelines. Participate in weekly project meetings to address technical questions, track progress, and maintain alignment with project managers. Support labeling conversion projects, updating specifications, conversion logs, and ensuring compliance with IVDR requirements. Assist in un-CE marking activities, ensuring product labeling reflects updated regulatory status and is aligned with specification documents. Update tracking logs, coordinate regional notifications, and communicate with the RA SAP restriction coordinator to manage product distribution restrictions where necessary. What You Bring Bachelor's degree in Biochemistry, Biology, Medical Technology, or a related scientific field. 3-5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD or medical device industry. Solid understanding of FDA and CE-marking requirements for IVD products (IVDR knowledge strongly preferred). Excellent communication, analytical, and problem-solving skills, with the ability to work both independently and collaboratively. Strong attention to detail, organization, and ability to manage multiple tasks within set deadlines. Proficiency with Microsoft Office, document control systems, and regulatory databases. 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. After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. About Advantage Technical With 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 AdvantageTechnical.com. 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 your local branch. 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. 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