We are seeking a detail-oriented Quality & Regulatory Affairs Specialist to support compliance activities and regulatory submissions. This role ensures that products meet all applicable quality standards and regulatory requirements, including those set by the U.S. Food and Drug Administration.
Key Responsibilities: Regulatory Affairs
- Prepare and submit regulatory filings (e.g., 510(k), IND, NDA)
- Ensure compliance with U.S. and global regulations
- Maintain regulatory documentation and records
- Coordinate with regulatory agencies, including the FDA
Quality Assurance
- Support and maintain Quality Management Systems (QMS)
- Ensure compliance with standards such as International Organization for Standardization (ISO 13485, ISO 9001)
- Assist with internal/external audits and inspections
- Manage CAPA, deviations, and change controls
Documentation & Compliance
- Review SOPs, batch records, and technical files
- Ensure Good Documentation Practices (GDP)
- Track and implement regulatory updates
Cross-functional Collaboration
- Work with R&D, manufacturing, and clinical teams
- Support product lifecycle and regulatory strategy
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or related field
- 1–5 years of experience in QA/RA (entry-level candidates with internships may be considered)
- Knowledge of FDA regulations (21 CFR, GMP, GLP)
- Strong attention to detail and documentation skills
Work Authorization
OPT, CPT, and H4 EAD candidates are welcomed
- Must have valid U.S. work authorization
Compensation
- $20 – $30 per hour (based on experience)
- Potential for extension or full-time conversion
Pay: $20.00 - $30.00 per hour
Benefits:
Work Location: In person
