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Responsibilities:
- Initiate regulatory and quality documentation.
- Assess design and production changes for regulatory needs.
- Author, review, and approve standard operating procedures.
- Conduct research on regulatory requirements and guidelines.
- Assist in regulatory filings preparation and submission.
- Maintain regulatory & quality system documentation.
- Support the regulatory team in responding to inquiries.
- Review marketing materials for regulatory compliance.
- Participate in cross-functional regulatory support meetings.
- Monitor changes in regulatory requirements.
- Support quality management systems development.
- Assist with continuous improvement initiatives.
- Assess design changes for regulatory impact.
- Additional duties as assigned.
Requirements:
- Bachelor’s degree in relevant scientific field.
- Working knowledge of FDA, CLIA, CAP, NY, and ISO standards.
- Knowledge of software used in medical devices or IVDs.
- Good technical writing skills.
- 1-3 years’ regulatory affairs experience in medical devices.
Benefits:
- Paid Time Off (PTO).
- Health, Dental, Vision, and Life insurance.
- 401k Retirement Savings Plan.
- Employee Discounts.
- Voluntary benefits.
