Regulatory Affairs Associate - CONSULTANT
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….
ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with 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 supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client's counterparts.
Job Title: Regulatory Affairs Associate - CONSULTANT
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 (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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