Regulatory Affairs Specialist III ID-1086
Overview
As a Bio-Rad Regulatory Affairs Specialist III you will support Bio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Regulatory Specialist.
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As part of Bio-Rad's Seattle Opeartions RA team, you'll apply your strong leadership skills and knowledge of regulatory requirements to ensure that our QMS and the products we distribute are in compliance to local and international regulations and applicable standards, escalate issues as necessary, complete necessary documentation and optimize our processes and procedures. You'll also work closely with Seattle Operations RA team and cross functional teams to ensure all the non-conformances are resolved and corrective actions are documented as needed.
How You'll Make An Impact:
What You Bring:
Location: Bio-Rad is pleased to offer the flexibility of Remote Work for this role anywhere in the U.S.
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 annual salary this position is $83,000 to $140,500 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 an offer, if applicable, and is based on several factors we believe fairly and accurately impact compenstion, 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.
As a Bio-Rad Regulatory Affairs Specialist III you will support Bio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Regulatory Specialist.
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As part of Bio-Rad's Seattle Opeartions RA team, you'll apply your strong leadership skills and knowledge of regulatory requirements to ensure that our QMS and the products we distribute are in compliance to local and international regulations and applicable standards, escalate issues as necessary, complete necessary documentation and optimize our processes and procedures. You'll also work closely with Seattle Operations RA team and cross functional teams to ensure all the non-conformances are resolved and corrective actions are documented as needed.
How You'll Make An Impact:
- Coordinate planning, approval, and execution of the annual internal Seattle Operations audit schedule and program.
- Facilitate external audit activity (Food and Drug Administration, Notified Body and Customer Audits).
- Lead and facilitate internal teams to ensure that external audit commitments such as responses and corrective actions to findings are completed in a timely manner.
- Prepare corporate and local standard operating procedures, training instructions, as well as inter-divisional company agreements.
- Document management: maintain and store current quality certificates, MOUs, contracts with auditing organizations, audit reports, Design History Files, and other records as assigned.
What You Bring:
- Bachelor's degree or equivalent in Biology, Chemistry, Medical Technology, or related field.
- Qualified Lead Auditor per Lead Auditor training and certification with a recognized accreditation body (ASQ certification preferred).
- 5 years experience in regulated industry or equivalent combination of education and experience with 3 or more years working in the area of quality management systems and/or regulatory affairs
- Working knowledge of global governing regulations, requirements, and standards such as 21 CFR Parts 803, 806, 820, 11, ISO 13485, ISO 14971, European IVD Regulation, and the Medical Device Single Audit Program / participating country regulations.
- Experience with Artificial Intelligence is preferred.
Location: Bio-Rad is pleased to offer the flexibility of Remote Work for this role anywhere in the U.S.
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 annual salary this position is $83,000 to $140,500 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 an offer, if applicable, and is based on several factors we believe fairly and accurately impact compenstion, 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.
