What are the responsibilities and job description for the Regulatory Affairs Specialist position at Advantage Technical?
Job Title: Regulatory Affairs Specialist II
Location: Hybrid – Core onsite days are Tuesday and Thursday; third onsite day is flexible Duration: 1 Year Contract - possible extension
Pay Range: $45–$50/hour
Position Overview
Join our client's Regulatory Affairs team to support the transition to the EU’s In Vitro Diagnostic Regulation (IVDR), impacting all CE-marked IVD products. This role plays a critical part in ensuring regulatory compliance by revising technical documentation, updating labeling, and coordinating regional notifications.
Key Responsibilities
- Technical File Management:
- Revise assigned technical files using the latest templates.
- Ensure each file clearly presents product details, performance expectations, and supporting evidence of conformity.
- Incorporate updated technical reports, validations, and test documentation.
- Complete each file within defined timelines and participate in weekly project meetings to report progress and resolve issues.
- Labeling Compliance:
- Support IVDR labeling conversion efforts through cross-functional collaboration.
- Maintain and update the labeling conversion tracking log based on manufacturing schedules, product fill dates, lot numbers, and change request references.
- Revise labeling specifications to meet IVDR requirements.
- Product De-Registration:
- Assist in un-CE marking selected products.
- Track progress until final labeling reflects required changes per specification documents.
- Regulatory Coordination:
- Update the technical file tracking log.
- Notify and track RA Regional updates related to labeling changes.
- Communicate with the RA SAP restriction coordinator to ensure product lot restrictions are properly implemented.
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.
- Familiarity with FDA and CE marking requirements for IVD products is preferred.
- Strong ability to work independently and collaboratively across teams.
- Excellent communication skills, including negotiation and persuasion.
- Proficient in analytical thinking, problem solving, and computer-based documentation.
- Deep understanding of regulatory policies, procedures, and best practices.
Salary : $40 - $50