Regulatory Affairs Specialist II

Bio-Rad is looking for a Regulatory Affairs Specialist II to join our Irvine, CA office. In this position you will support new product developments/product modifications, IVDR implementation, and international product registrations. Also you will represent RA on global project teams for new or modified in vitro diagnostic devices (IVD).

 

How You'll Make An Impact:

• Manage global RA Change Request Process and ensure these are tracked in a log and all files completed and are audit ready.
• Create and maintain technical files in compliance with CE Marking.
• Support international product registrations: license updates and renewals in accordance with country specific requirements.
• Ensure labeling changes are implemented and communicated to the selling regions, as needed.
• Support Field Action activities and ensure all documentation is audit ready.
• Manage SAP product restrictions.
• Participate in review and implementation of new and/or revised external regulatory standards and approval of marketing materials.
• Support internal audits for MDSAP and IVDR requirements.
• Manage QS product global registration and licensing to support QS revenue.
• Effective communication skills, both written and oral with cross functional teams.
• Strong documentation, prioritization, and organization skills.

What You Bring:

• Bachelor’s degree in biology, chemistry, medical technology or related field.
• Advance degree and/or Regulatory Affairs Certification are a plus.
• 2+ years' experience in domestic and international regulatory compliance and experience in the IVD industry.
• Working knowledge of FDA and CE Mark requirements and of RA policies, practice, and procedures.
• Working knowledge of product labeling requirements and international product registrations.
• Knowledge of product labeling requirements.
• Strong customer orientation and focus.
• Detail oriented with strong technical writing skills.
• Excellent computer applications skills and able to perform basic statistical analysis.
• Analytical, communication, problem solving, computer, and critical thinking skills.

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 Irvine, 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, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!  

 

Compensation: The estimated base salary range for this position is $82,000 - $112,800 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 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.  #LI-AK1 #LI-Hybrid

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