To Apply for this Job Click Here
You are a detail-oriented Regulatory Affairs professional with 3–5 years of experience in RA, QA, R&D, Manufacturing, or Project Management within the In Vitro Diagnostics (IVD) industry. You are knowledgeable in FDA and CE marking requirements and skilled in technical documentation, labeling, and cross-functional collaboration.
This position pays: $45 – 50/hr.
What you will be doing:
-
Supporting the EU’s In Vitro Diagnostic Regulation (IVDR) transition for all CE-marked Bio-Rad products.
-
Revising and updating technical files to meet IVDR requirements using the latest templates and documentation.
-
Participating in weekly meetings to resolve issues, provide updates, and meet project deadlines.
-
Assisting in the IVDR labeling conversion project by updating specifications, tracking logs, and coordinating with cross-functional teams.
-
Managing the un-CE marking process for select products and ensuring final labeling reflects required changes.
-
Performing miscellaneous activities including updating tracking logs, notifying regional RA teams of labeling changes, and coordinating product restrictions in SAP.
What you bring:
-
A Bachelor’s degree in biochemistry, biology, medical technology, or a related field.
-
3–5 years of experience in regulatory affairs or a related discipline within the IVD industry.
-
Strong understanding of FDA and CE regulatory requirements (IVD experience preferred).
-
Excellent analytical, communication, problem-solving, and computer skills.
-
Ability to work both independently and collaboratively in a fast-paced environment.
-
Solid understanding of RA policies, practices, and procedures.