Quality Regulatory Compliance Technician at Aidance Scientific Inc in Woonsocket, Rhode Island

Job Description:

Regulatory/Compliance Technician supports the Quality Department with activities necessary for general regulatory maintenance/surveillance of products in a timely manner.

• Support all protocol development and regulatory research


• Assist in drug registrations with the FDA for existing products


• Participate with internal audits and corrective action reports


• Work with customers/suppliers/external labs to ensure overall regulatory compliance


• Monitor emerging State and Federal regulatory changes and identify solutions for compliance


• Develop SOP’s in accordance with the organizational practices and compliance


• Assist with packaging claims


• Assists with artwork approval process


• Work at the direction of the Quality Assurance Manager on other special projects as they arise


• Coordinate and submit the testing required for each product/sample to outside laboratory


• Daily communication with outside laboratory to receive result data


• Document and analyze results data for each product/sample


• Coordinate retesting of product/samples as needed to support quality investigations


• Performs other duties as assigned

Years of Experience:  0-2 years work-related experience in FDA regulated industry

Education:  Bachelor’s Degree in Life Science related discipline or related work experience

Additional Information:  Understanding of FDA regulatory requirements

• Strong knowledge of Word, Excel, and PowerPoint


• Excellent verbal, written communications skills


• Strong attention to detail, convey information clearly, concisely, accurately, and effectively.


• Excellent interpersonal skills necessary to establish and maintain effective working relationships


• Strong team player, with the ability to multi-task and handle multiple priorities.


• Good organizational and time management skills.