Regulatory Affairs Specialist I

Company: Bio-Rad Laboratories
Location: Irvine
Posted on: March 11, 2023

Job Description:

Bio-Rad Laboratories is seeking a Regulatory Affairs Specialist who will support the RA team activities such as global product registrations, EU IVDR implementation, product restrictions, etc. The individual in this position will be working both independently and in a team-oriented environment.How You'll Make An Impact:

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• Support the team with global product registrations for assigned products by timely submitting registration dossier to countries, support queries from regional RAs, manage change notifications, weekly participation in meetings, etc.
  
• Manage product restrictions/releases in SAP based on product's approval status.
  
• Support the implementation of EU's In Vitro Diagnostic Regulations for the products assigned by generating technical files, updating labeling to comply with IVDR requirements, or any related activities.
  
• Provide regulatory support with product related requests from internal/external customers.
  
• Assist with the meeting EUDAMED/GUDID requirements for marketed products.
  
• Review promotional and advertising materials for traditional market products including product sheets and catalogs, etc.
  What You Bring:
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  • Bachelor's degree in biology, chemistry, medical technology or related field.
    
  • Advance degree and/or Regulatory Affairs Certification are a plus.
    
  • 0-2 years experience in domestic and international regulatory compliance in the medical device industry.
    
  • Knowledge of FDA and CE Mark requirements.
    
  • Knowledge of product labeling requirements.
    
  • Strong customer orientation and focus.
    
  • Able to work independently and with others.
    
  • Effective communication skills, both written and oral.
    
  • Strong documentation and organizational skills.
    Location: Bio-Rad is pleased to offer the flexibility of a Hybrid Work Environment for this role, 3 days on, 2 off, 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 $71,600 to $98,500 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 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.#LI-JM1

Keywords: Bio-Rad Laboratories, Irvine , Regulatory Affairs Specialist I, Other , Irvine, California