• Regulatory Affairs Manager

    Location US-CA-Irvine
    Requisition ID
    # of Openings
  • Overview

    The RA Manager II is responsible for the strategic leadership, management and oversight of Regulatory Affairs at QSD to meet division and customer needs throughout the total product lifecycle while assuring compliance with domestic and international regulatory requirements. Responsibility includes oversight of regulatory activities for multiple sites and a key liaison with agencies and inspectors.  


    • Bachelor’s degree in Biology, Chemistry, Molecular Biology, Clinical Laboratory Science or related field. Advanced degree is recommended.
    • Regulatory Affairs Certification is preferred.
    • 8+ years’ relevant regulatory leadership and management experience is required, or an equivalent combination of education and experience working in an FDA QSR and ISO 13485 regulated environment for a medical device manufacturer.
    • Demonstrated ability to develop options and pathways to compliance considering customer and regulatory requirements, risk and business needs.
    • Extensive knowledge and application of FDA, CE Mark, MDSAP, and global regulatory requirements for diagnostic products that includes new product development and design control activities. 
    • Background required in the preparation and review of global regulatory submissions including FDA premarket notifications, CE design dossiers and technical files.
    • Experience in regulatory authority notifications for adverse events, field safety corrective actions, and other CAPA-related activities.
    • Experience in the implementation of new standards and regulations.
    • Strong Customer Orientation and Focus
    • Effective Communication Skills (Written and Verbal)


    What’s in it for you?

    • Competitive pay and great benefits including medical, dental, vision, 401k and more
    • Opportunities for growth and training
    • Stability of a profitable 60+ year old company
    • Great work environment
    • Satisfaction in working at the cutting edge of biotech, and seeing your work make a difference in the world.

    About Bio-Rad:


    Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.


    Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results. 


    EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age Employer


    To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.


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