Regulatory Affairs Specialist II

Bio-Rad is looking for a Regulatory Affairs Specialist II to join our Irvine, CA office. In this position you will support new product developments/product modifications, IVDR implementation, and international product registrations. This position must be based in Irvine, California hybrid (onsite Tuesday-Thursday) and requires the employee to be located within commuting distance of the office. How You'll Make An Impact As a Regulatory Affairs Specialist II, you will support new product developments/product modifications, IVDR implementation, and international product. Represent RA on global project teams for new or modified in vitro diagnostic devices (IVD). Manage global RA Change Request Process and ensure these are tracked in a log and all files completed and are audit ready. Create and maintain technical files in compliance with CE Marking. Support international product registrations: license updates and renewals in accordance with country specific requirements. Ensure labeling changes are implemented and communicated to the selling regions, as needed. Support Field Action activities and ensure all documentation is audit ready. Manage SAP product restrictions. Participate in review and implementation of new and/or revised external regulatory standards. Participate in review and approval of marketing materials. Support internal audits for MDSAP and IVDR requirements. Manage assigned tasks as needed. What You Bring Bachelor's degree in Biology, Chemistry, Medical Technology, or a related scientific discipline. Advanced degree and/or Regulatory Affairs Certification (RAC) preferred. Minimum of 2 years of experience in domestic and international regulatory affairs or regulatory compliance, preferably within the in vitro diagnostics (IVD) industry. Working knowledge of FDA regulations, CE Marking requirements, and Regulatory Affairs policies, practices, and procedures. Working knowledge of international product registration processes and country-specific regulatory requirements. Knowledge of medical device and IVD product labeling requirements. Strong customer focus with the ability to build effective cross-functional relationships. Detail-oriented with excellent technical writing and documentation skills. Proficient in Microsoft Office applications and other business systems, with the ability to perform data analysis. Strong analytical, communication, problem-solving, organizational, and critical thinking skills. Benefits We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more! Compensation The estimated base salary range for this position is $86,000 - $119,200 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is also eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance. Who We Are For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. EEO Statement Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply. #J-18808-Ljbffr