What are the responsibilities and job description for the Regulatory Affairs and Quality Assurance Manager position at Sri Trang USA?
POSITION: Regulatory Affairs and Quality Assurance Manager
LOCATION: Chicago, Illinois
REPORTS TO: President
DATE: November 29th, 2024
JOB SUMMARY:
Manages Quality Assurance and Regulatory Affairs for parent organization’s USA office, ensuring that quality system requirements are effectively established and effectively maintained in accordance with all applicable requirements in coordination with the home office.
JOB FUNCTIONS AND RESPONSIBILITIES
1. FDA Official Correspondent and QMR. US Agent for parent organization.
2. Manage CBP’s C-TPAT Membership.
3. Oversee relevant aspects of vendor (Warehousing, Logistics, Facilities, Security) qualification and monitoring as it relates to QA/RA/C-TPAT requirements.
4. Point of contact regarding import entry information requests, forwarders, filers, holds, sampling, refusals or other actions.
5. Maintain a working knowledge and awareness of applicable government (FDA, Health Canada, FTC) and State Regulations. Work with parent organization on regulatory submissions.
6. Participate in reportable event filing determinations and submit filings as required to relevant North American national authorities including to support parent organization.
7. Conduct initial regulatory review for North American artwork as per the Organization’s artwork review system.
JOB REQUIREMENTS/QUALIFICATIONS
1. Bachelor’s degree or equivalent experience in life sciences, engineering or related field
2. At least 3 years of relevant quality assurance or regulatory affairs experience in the medical device industry
3. Experience developing and maintaining SOPs
4. Ability to build relationships with other areas of the business, outside clients, and regulatory agencies
5. Must be detail oriented
6. Must have a valid passport and ability to travel overseas for factory visits, training, seminars, or customer visit as needed.