Regulatory Compliance Specialist

3 weeks ago


Boston, Massachusetts, United States RQMIS Inc Full time
Job Summary

RQMIS Inc is seeking an experienced Senior Quality Assurance Analyst Medical Devices to join our team. As a leading medical device and biotechnology consultancy, we offer a unique opportunity to work on high-profile projects and collaborate with top experts in the field.

About the Position

This role involves assisting clients in ensuring compliance with relevant regulations, including GMPs, QSR, ISO 9001, and IEC 62304. You will be responsible for auditing client quality systems, developing and implementing tools, and designing and implementing IQ/OQ/PQ for client equipment and processes.

This is a salaried position with a competitive compensation package of $110,000 per annum, based on industry standards and location. You will also enjoy a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

Key Responsibilities
  • Implement software quality systems that meet regulatory requirements.
  • Audit client quality systems for compliance with FDA's QSR, ISO 13485, and other regulations.
  • Develop and implement tools for employees to conduct their activities efficiently.
  • Design and implement IQ/OQ/PQ for client equipment and processes.
Requirements and Qualifications
  • Bachelor's degree in computer science, engineering, or a scientific field.
  • 6-10 years' experience in drug, biologics, tissue regulations, and standards.
  • Strong attention to detail, computer skills, and leadership abilities.


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