Regulatory Affairs Associate - CONSULTANT
ClinChoice is searching for a Regulatory Affairs Associate Consultant for a 12‑month contract with the possibility of extension to join one of our clients. ClinChoice is a integral full‑service CRO with a strong focus on quality, professional development, and a supportive culture.
Location: Mexico Remote
Responsibilities
- Collect, review, and upload product, licensed product, and license data in databases (e.g., UDI, eligibility, etc.)
- Review, execute and drive eligibility releases as per required procedures
- Review, track and monitor critical Notified Body mailbox and invoices
- On a project/product basis, facilitate change orders for DEC/DoC/DD and other documents in the PLM system(s), and assist with strategy creation, follow‑up on local assessments and creation of relevant documentation (e.g., letters to file)
- Maintain/update in all relevant databases and sources (e.g., GRID for document self‑serve)
- On a project basis, monitor, track and execute regulatory operational processes as required
- Perform other tasks as required
Minimum Requirements
- Bachelor’s degree (life sciences preferred)
- Basic knowledge of US FDA QSR, ISO13485, EU MDD/MDR
- Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
- Strong proficiency in written and verbal English communication is required.
Key Words: Regulatory Affairs, Regulatory Compliance, EU MDD/MDR
Seniority level: Entry level
Employment type: Full-time
Job function: Legal
Industries: Pharmaceutical Manufacturing
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