What are the responsibilities and job description for the Regulatory Affairs Specialist position at Advantage Technical?
Regulatory Affairs Specialist I – In Vitro Diagnostics (IVD)
Company Overview
A global life‑science organization specializing in clinical diagnostics and laboratory technologies is seeking a Regulatory Affairs Specialist I to support regulatory activities across multiple IVD product lines. The company develops and manufactures diagnostic solutions used in clinical laboratories worldwide and is committed to advancing high‑quality, compliant products that improve patient outcomes.
Position Summary
The Regulatory Affairs Specialist I provides regulatory support for IVD products across several diagnostic product groups. This role focuses on preparing low‑ to medium‑complexity regulatory submissions for global product registrations, maintaining technical documentation, and supporting change‑control activities. Daily collaboration with cross‑functional partners—including technical writers, desktop publishing, regulatory colleagues, marketing, R&D, quality, planning, and manufacturing—is essential.
Key Responsibilities
Regulatory Documentation & Submissions
- Prepare, assemble, and review regulatory submissions of low to moderate complexity to support worldwide product registrations.
- Maintain and update IVD technical documentation, including IVDR technical files.
- Monitor and evaluate change requests to ensure regulatory compliance and proper documentation.
Cross‑Functional Collaboration
- Work closely with technical writers, desktop publishing teams, and regulatory specialists to ensure accurate and compliant documentation.
- Partner with Marketing, R&D, Quality Assurance, Planning, and Manufacturing to gather information, clarify requirements, and support regulatory needs.
Compliance & Technical Support
- Apply basic analytical, communication, and problem‑solving skills to meet daily regulatory responsibilities.
- Support interpretation of scientific reports, risk management documentation, and quality system requirements.
- Assist in maintaining regulatory databases and electronic systems used for document control and submissions.
How You’ll Make an Impact
- Prioritize multiple projects effectively while meeting deadlines in a fast‑paced environment.
- Communicate clearly and professionally with colleagues across diverse departments.
- Maintain strong organizational habits and attention to detail.
- Demonstrate technical aptitude for understanding IVD product features and regulatory expectations.
- Navigate electronic systems and databases with confidence.
What You Bring
Education
- Bachelor’s degree in Biology or a related scientific discipline.
Experience
- 6 months to 2 years of experience in IVD regulatory affairs.
- Laboratory research experience in a regulated IVD or medical device environment strongly preferred.
Skills & Knowledge
- Proficiency with Microsoft Office applications (Excel, Word, PowerPoint, Teams).
- Understanding of scientific documentation, risk management principles, and quality system requirements.
- Strong written and verbal communication skills.
- Ability to work collaboratively and maintain accuracy in a detail‑oriented role.