Regulatory Affairs Associate Full Time NEW

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.