Regulatory Coordinator
Found in: Resume Library US A2 - 2 weeks ago
Responsibilities
Assist in the preparation, submission, and maintenance of regulatory filings and registrations, including 510(k) and PMA submissions.
Interpret and communicate industry and regulatory guidance to internal teams.
Coordinate with cross-functional teams to ensure compliance with regulatory requirements.
Manage documentation related to regulatory submissions and approvals.
Prepare post-market surveillance reports, adverse event reports, and other regulatory reports.
Track and maintain regulatory compliance metrics.
Participate in regulatory agency inspections.
Requirements
Proficient in English and Chinese
Bachelor's degree in biology, chemistry, or a related field.
2+ years of experience in regulatory affairs in the biotechnology industry.
Knowledge of FDA regulations, including 21 CFR, 510(k), and PMA requirements.
Strong organizational and project management skills.
Excellent written and verbal communication skills.
Ability to work collaboratively with cross-functional teams.
Detail-oriented with strong analytical skills.
Benefits
Health Care Plan (Medical)
Retirement Plan
Paid Time Off
Training & Development
Company Sponsored Meals
Individual and Team Bonding Spending
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