Regulatory Affairs Associate I
Randstad USA · North Chicago, IL · 1 wk ago
HybridLegal$29–$32.29/hrContract
Job Summary
Responsibilities
- Manage, compile, and author CMC sections and CTD content for marketed product variations.
- Partner with RA CMC Project Leads to develop Module 3 content and project timelines.
- Independently facilitate project team meetings and run review meetings for submission documents.
- Author and submit PMA supplements, including 30-day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
- Review and approve manufacturing changes, engineering study protocols, and validation reports for Class III implantable medical devices.
- Career: Contract
- Salary: $29.00 - 32.29 per hour
- Work Hours: 9 to 5
- Education: Bachelors
Qualifications
- Required Skills:
- Degree: BA/BS in Chemical, Biological Sciences, or a relevant discipline.
- Experience: 1-2 years of pharmaceutical industry experience and 1-2 years of cross-functional project management.
- Technical: Experience authoring/submitting Class III implantable PMA supplements; knowledge of FDA PMA guidance and CFR regulations.
- Systems: Proficiency with electronic document management systems.
- Preferred Skills:
- Experience specifically in Regulatory Affairs, R&D, or Manufacturing (focused on CTD Module 3).
- Familiarity with US and international regulatory dossier requirements.