Regulatory Affairs Specialist
$46,800–$52,000 year
Hybrid · Irvine, California, United States
Irvine, California, United StatesHybridFull Time$46,800–$52,000 yearMid LevelBachelors DegreeUnknown
Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
As a Regulatory Affairs Specialist II, the role involves supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities for CE marked products. Key responsibilities include revising technical files, updating product labeling for compliance, and collaborating across teams while managing timelines and tracking logs. Candidates should have a Bachelor's degree and relevant experience in the IVD industry.
Required Qualifications
- Bachelor's degree in Biochemistry, Biology, Medical Technology, or a related field
- 3–5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry
Desired Qualifications
- Knowledge of FDA and CE marking requirements for IVD products
- Strong ability to work both independently and in a collaborative environment
- Excellent communication skills, with the ability to negotiate and persuade effectively
- Proven analytical, problem-solving, critical thinking, and computer skills
- In-depth understanding of Regulatory Affairs policies, practices, and procedures
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