Quality Manager I

As the PSUR QA Manager on our RA/QA team you will ensure Post Market Surveillance reporting requirements related to IVD products are planned and completed per established plans and applicable standards and regulations (IVDR, MDSAP, etc.). You will be responsible for Regulatory Compliance (PRRC) under EU IVDR for post market surveillance reporting activities. Also act as subject matter expert for IVDR Post Market Surveillance requirements and provide support during inspections by regulatory authorities.

 

You will be responsible for day-to-day operations of the IVDR post market surveillance reporting activities including developing and maintaining a global schedule of PMS reporting deliverables (PSURs, PMSRs), allocating resources to support activities and coordinating with business partners on needed support to achieve reporting timelines. Present PMS program performance and health to management (product review meetings, Management Reviews and business review meetings) and escalate critical issues and risks to senior management.

 

How You Will Make an Impact:

• Lead a global team gathering, analyzing and reporting product information related to IVDR requirements for Bio-Rad’s In-vitro diagnostics products (IVD).
• Ensuring Post Market Surveillance (PMS) plans are aligned with product technical file submissions and applicable post market tracking and trending procedures depending on product classifications.
• Developing and maintaining product Post Market Surveillance Plans and Reports by gaining cross functional alignments and approval.
• Collaborate with business partners to continually assess existing PMS support processes to identify gaps and areas of improvement to ensure compliance to applicable regulatory requirements (EU IVDR, ISO 13485, 21 CFR Part 820, MDSAP and others). This includes working with software system owners and IT to identify new and/or improvements to existing systems and tools to improve data collection and reporting.
• Design, develop, implement, maintain and continuously improve related processes and global procedures to ensure compliance with applicable internal and external quality and regulatory requirements including identification, management and escalation of identified issues and risks to appropriate business partners and senior management.
• Act as owner of global procedures related to Post Market Surveillance including ensuring global business partners are trained and aware of requirements impacting their support of PMS activities.

 What You Bring:

• Education: Bachelors degree in Engineering, Biology, Chemistry or related field.
• Work Experience: 5+ years experience in regulated manufacturing industry or equivalent combination of education and experience.
• Experience working in the medical device, pharmaceutical or other regulated industry. Thorough knowledge of medical device/drug/biotech manufacturing process and experience with risk management regulations and standards, including FDA 21 CFR 820, MDSAP, IVDR, ISO 13485 and ISO 14971.
• Experience as a GMP and/or ISO trainer is highly desirable.
• Experience working in a global organization and/or interfacing with multiple manufacturing locations a plus.
• Communication, decision-making under stressful conditions, word processing, and spreadsheet and negotiation skills required.
• Successful candidates will actively seek interaction with others, under potentially challenging time pressures, in order to resolve difficult technical issues.

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 $102,200 to $140,500 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.

 

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.

 

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