Regulatory Affairs Specialist IV

Job Posted 9/26/2023
Bio-Rad Laboratories, Inc.
5731 W. Las Positas Blvd
Seattle, WA
United States
Category BioTech
Job Description

As a Regulatory Affairs Specialist IV you will support Bio-Rad's commitment to quality and compliance by coordinating the Domestic and International Registration Requests.  You’ll apply your strong leadership skills and knowledge of regulatory requirements to ensure that we register and distribute products that 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 Regulatory Affairs and cross functional teams to ensure all the product and facility registration activities are complete and change assessments are documented as needed.


How You'll Make An Impact:

  • Help to create and foster a quality environment and mindset throughout the business by coordinating the Domestic and International Regulatory Registrations, Regulatory Change Assessment including weekly meetings, workflows and documentation, and escalations.

  • Maintain the consistency of high quality standards across Bio-Rad by aligning local and regional procedures with our global processes and expectations.

  • Drive change and transform the way we tackle challenge with support for additional quality and compliance activities, including audits and inspections.

What You Bring: 

  • Educaton: Bachelor's degree, or equivalent, in Biology, Chemistry, Medical Technology, or related field.

  • Work Experience: Minimum of 8 years experience in Regulatory Affairs, or equivalent combination of education and experience relating to IVD/Medical Devices/Biologics.

  • Proficiency in interpretation and application of US regulatory requirements for IVD/Medical Devices/Biologics including submissions experience for PMA and/or BLA products.

  • Proficiency in interpretation and application of EU regulatory requirements for IVD/Medical Devices including submissions experience for Class C and D IVD or equivalent risk class Medical Device products.  

  • Ability to manage multiple complex projects with defined timelines. Excellent written and verbal communication skills required for negotiation with internal and external parties.

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 hourly range for this position is $107,200 to $147,400 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 disabilities, and people of all races, ethnicities, genders, ages, and orientations 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.