Regulatory Affairs Specialist jobs in Woonsocket, RI

Sentec is a market leader of non-invasive respiratory monitoring solutions who develops,
manufactures, and markets patient-centric, cost-effective technologies and products that provide
clinicians with greater insight to quickly identify trends, rapidly and more accurately assess patient
respiratory status, and make more well-informed, timely care decisions – decisions that can improve
patient care. We aim to improve the lives of patients by advancing non-invasive patient care by
empowering clinicians with clinically superior monitoring and therapeutic technologies.

Watch the Sentec Company Video

Summary:
Responsible for registrations of Sentec products in the US and Canada, the Regulatory Affairs
Specialist acts as the local representative and contact person for the competent authorities. Will work
closely in conjunction with, and as an extension of, the Sentec regulatory compliance team based in
Switzerland.

Essential Duties and Responsibilities:

• Continuous monitoring and implementation of updated regulatory requirements and

• Support development of the regulatory strategy to receive product clearances in conjunction

• Compilation of submission dossiers for new product approvals and changes to existing

• Serve as the primary local representative and contact to the FDA and Health Canada and other

• Participate in regulatory inspections/audits by internal and external audit authorities and

• Perform risk assessment of the obligation to report incidents and customer complaints in the

• Support partner companies (suppliers, dealers) regarding regulatory issues as needed.
• Act as regulatory representative on cross-functional project teams to develop regulatory

strategies, testing requirements, and other documentation to ensure that regulatory
submissions are prepared and approved to meet launch timelines for new and modified
products.

• Review product, supplier, and manufacturing changes as well as verification and validation

• Support Quality teams by providing guidance and serving as a resource in the development

• Review and approve of labeling documents with focus of compliance to pre-defined claims and

• Travel to Sentec facilities in North America and Switzerland as needed (anticipated 3-6 times

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.

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