Lincoln, Rhode Island
Product registrations and submissions in the US and Canada, working closely with the regulatory compliance team in Switzerland.
Review product, supplier, and manufacturing changes for compliance with applicable regulations and procedures.
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)
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.
- 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.
Life at Sentec
Sentec employees have access to competitive benefits packages, paid parental leave, tuition reimbursement and more. Sentec offers a place to thrive and make an impact as a small company with huge potential and an expanding track-record of consistent growth. We know our decisions matter to the future of the company, our voices are heard by leadership and our hard work pays off. Sentec consists of an eclectic group of people dedicated to help deliver products to healthcare providers that make a difference and improve patient care. We love that we can log off each day knowing we’ve made a difference.