Regulatory Affairs IV

As part of our RA/QA team, you will provide coordination of the internal and external audit program for IVD medical device GMP facility for instruments, software and reagents within Clinical Diagnostic Group. You will also  be responsible for facilitating the management of the quality management system audit program and reporting to management. This includes a board range of regulatory inspections (FDA, notified body, other country GMP audits). Your responsbilities will include conducting audit readiness activities, plan the yearly audit schedule, and conduct internal audits over several facilities. Finally, you will provide leadership to run and implement the new standards and regulations assessment program and report to management.

How You’ll Make An Impact: 

• Coordinate, prepare, execute and deliver quality audits based on a planned audit schedule in a GMP regulated environment. This includes managing audit checklists, audit reports, response to non conformances and effectiveness checks. Provide metrics to management on internal and external audits. 
• Excellent written and verbal communication skills in English across multiple departments, employees and levels of management. 
• Highly organized and detail-oriented. Good time management. Strong quality mindset. 
• Experience in organizing quality audits for regulatory inspections (FDA, Notified body) and provide documentation to support GMP paper audits for international subsidiaries. International subsidiaries have paper GMP paper audits to fulfill requirements for international registration. 
• Experience with interpretation of ISO standards, FDA guidance, and regulations. Implement new regulations within the quality management system, as required.

What You Bring: 

• Education:BS or advanced degree in Biology or bioengineering with emphasis in regulatory science as a plus. 
• Work Experience: 5-7 years experience auditing in a regulated ISO or FDA manufacturing facility or equivalent experience. 
• Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Visio), and Adobe Acrobat Pro. Ability to provide quality metrics for executive management review. 
• Quality-centric mindset to ensure that the quality management system is operational according to regulations. 
• Ability to lead an audit team cross functionally as well as work independently without direct reports.

Location: Bio-Rad is pleased to offer the flexibility of a hybrid work environment for this role, 3 days in office, 2 days remote, working out of the Hercules, CA office.

 

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. 

 

Compensation: The estimated base salary range for this position is $114,700 to $150,000 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 eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance

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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. #LI-AK1

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