Regulatory Compliance Specialist
2 days ago
CorDx, a leading biotechnology company, is seeking an experienced Regulatory Compliance Specialist to ensure seamless regulatory operations. This role involves coordinating with cross-functional teams to guarantee compliance with industry regulations and guidelines.
About the RoleThe ideal candidate will possess excellent organizational and communication skills, enabling them to effectively interpret regulations and communicate industry guidance to internal teams. Proficiency in English and Chinese is also essential for this position.
Key Responsibilities- Regulatory Filing Management: Assist in preparing, submitting, and maintaining regulatory filings and registrations, including 510(k) and PMA submissions, ensuring timely completion and accuracy.
- Industry Guidance Communication: Interpret and communicate industry and regulatory guidance to internal teams, ensuring alignment with company policies and procedures.
- Team Collaboration: Coordinate with cross-functional teams to guarantee compliance with regulatory requirements, fostering open communication and collaboration.
- Documentation Management: Manage documentation related to regulatory submissions and approvals, ensuring up-to-date and accurate records.
- Reporting: Prepare post-market surveillance reports, adverse event reports, and other regulatory reports, adhering to established timelines and quality standards.
- Language Skills: Proficient in English and Chinese.
- Education: Bachelor's degree in biology, chemistry, or a related field.
- Experience: 2+ years of experience in regulatory affairs in the biotechnology industry.
- Knowledge: In-depth knowledge of FDA regulations, including 21 CFR, 510(k), and PMA requirements.
- Skillset: Strong organizational and project management skills, excellent written and verbal communication skills, ability to work collaboratively with cross-functional teams, and detail-oriented with strong analytical skills.
- Healthcare Plan: Comprehensive medical coverage.
- Retirement Plan: Company-sponsored retirement savings plan.
- Paid Time Off: Generous paid time off policy.
- Training & Development: Opportunities for professional growth and development.
- Company Sponsored Meals: Enjoy complimentary meals at company events.
- Individual and Team Bonding Spending: Funds for team-building activities and personal development.
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