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Job Number: 2170644

Job Title: Regulatory Affairs Specialist

Location: Irvine, CA
Compensation: $36/hr. - $45/hr. DOE

Nelson Staffing is currently hiring a Regulatory Affairs Specialist in the city of Irvine, CA.

The Regulatory Affairs Specialist will be providing support to the QSD department with all new regulations, and implementation of new IVDR labeling. This will involve all aspects of tracking and administer multiple activities including changes requested, manufacturing timelines for the associated product lot numbers, RA regional notifications, and RA Regional follow-ups and product restrictions as required.

Responsibilities:

  • Provide regulatory support on QSD products that will be transitioning from IVDD to IVDR CE Marking.
  • Manage and update IVDR labeling conversion log, and assure all documentation is prepared and processed timely to meet the manufacturing schedule.
  • Generate the regional RA documents in support of the labeling conversion including "no impact letters", country-specific declarations of conformity, letters of authorization.
  • Ensure risk management documents are generated and available for regional RA as requested.
  • Work with stakeholders and conduct weekly meetings to ensure change requests have been assembled and numbers assigned. Revisions to first of codes and labeling artwork are on track.
  • Ensure final IVDR labeling artwork is included in the IVDR technical files.
  • Assist, as needed in the generation of change requests folders for products based on the IVDR labeling conversation log.
  • Follow up with Marketing to obtain supporting documentation for products that will be un-CE marked or obsolete.

Education and Qualifications:

  • Bachelor's degree in biochemistry, biology, medical technology, or related fields
  • 2 - 5 years' experience in regulatory affairs, and, or experience in QA, R&D, Manufacturing or Project Management within the IVD industry.
  • Working knowledge of FDA and CE marking requirements for IVD products is a plus.
  • Able to work with minimal supervision
  • Excellent computer applications skills
  • Strong customer orientation and focus
  • Effective communication skills, both written and oral
  • Strong documentation and organizational skills
  • Strong tact and negotiation skills
  • Excellent people skills

Qualified candidates, please submit your resume and call to schedule an interview at (949) 345-5633.


About Nelson:

If you're looking for a new opportunity, the recruiting and staffing experts at Nelson can help. We work with companies of all types and sizes across all industries. We help people like you find exciting roles with employers ranging from Fortune 100, government, and nonprofit organizations to local businesses, industry leaders, and the most agile start-ups. The candidates we work with appreciate our responsive approach, genuine relationships, and exceptional service. With a commitment to transparency, authenticity, and credibility, we look forward to our jobs every day, and we're excited to help you find the job you've been looking for. Nelson is an EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.