Regulatory Affairs Manager II

Job Posted 4/2/2024
Bio-Rad Laboratories, Inc.
5731 W. Las Positas Blvd
Irvine, CA 92618
United States
Category BioTech
Job Description

As a Regulatory Affairs Manager II, you will be responsible for the strategic leadership, management, and oversight of Regulatory Affairs teams at QSD to meet business and customer needs throughout the product lifecycle while assuring compliance with domestic and international regulatory requirements. This position is also responsible for oversight of regulatory activities for multiple sites and acting as key liaison with agencies and inspectors.   


How You'll Make An Impact:

  • Advise site-based teams of appropriate actions in response to identified product compliance requirements.

  • Lead QSD Regulatory Affairs team to meet business needs for product premarket approvals, clearances, and registrations needed to serve global customers and meet financial goals.

  • Build, train, lead, and mentor strong forward thinking strategic teams. Develop department staff to be solutions oriented, consistent, timely, creative, and proactive support personnel.

  • Assure facilities are prepared for successful external audits and inspections.

  • Manage RA Department finance activities through budget development and management to approved budget.

 What You Bring:

  • 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.

Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well.  That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.


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 $149,000 - $204,800 at the time of posting. This range is inclusive of all geographic locations within the United States. 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, i,ncluding 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. Recently voted a Best Place to Work, 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.


Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.


Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. 


Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.