Regulatory Affairs Manager jobs in Woonsocket, RI

Sentec is a market leader of non-invasive respiratory monitoring and intrapulmonary percussive
ventilation (IPV) solutions who develops, manufactures, and markets patient-centric, cost-
effective technologies and products. We aim to improve the lives of patients by advancing non-
invasive patient care by empowering clinicians with clinically superior monitoring and therapeutic
technologies.

Regulatory Affairs Manager

Key Tasks:

• Product registrations and submissions in the US and Canada, working closely with the regulatory compliance

• Review product, supplier, and manufacturing changes for compliance with applicable regulations and

• Works cross-functionally to develop regulatory strategies, testing requirements, and other documentation.
• Perform risk assessments and if required, report incidents to the authorities.
• Stay abreast of regulatory requirement updates and standards.
• Travel to Sentec facilities in North America and Switzerland as needed (anticipated 3-6 times annually)
  

Our Offer:

• Working environment in a growing company.
• Directly influence on the quality of our products and make a difference for patients worldwide.
• Opportunities for professional and personal growth.
  

Your Profile:

• Bachelor’s degree required.
• 5 years’ experience in a Regulatory Affairs position within the medical device industry.
• In depth knowledge of regulatory framework of medical devices for the FDA and Health Canada/MDSAP.
• Analytical thinking and ability to compile scientific data and summarize results.
• Fluent in English.
  

To apply, send your resume to jobs.us@sentec.com