Coordinator, Medical Program

Intertek•Boxborough, MA

16h•Remote

About The Position

Intertek's Business Assurance team goes beyond testing, inspection and certification to look at the underlying elements that make a company and its products successful. Our assurance solutions provide confidence and total peace of mind that a client's operating procedures, systems and people are functioning properly to provide a competitive advantage in the marketplace. Intertek is continually innovating and evolving to reduce risk for consumers, brands and organizations in every sector and industry around the world. We go beyond Testing, Inspection and Certification of products: we are a Total Quality Assurance Provider to industries worldwide. Our Purpose: Bringing quality, safety, and sustainability to life. The Medical Program Coordinator is responsible for collaborating with our clients and other functions, including our Medical Notified Body, to support their medical certification (ISO 13485/MDSAP/MDR) projects.

Requirements

Bachelor's Degree
Strong analytical, organizational, communication and creative critical thinking skills
Technologically savvy and proficient with Microsoft Office suite
At least 2 years of experience with quality management systems
This is a remote position; however, applicants must reside in and be able to legally work in the United States.

Nice To Haves

Work experience includes direct QMS responsibilities.
Experience working for a medical device, pharma, cosmetics, and/or dietary supplement company.
Experience working for a registrar/AO/Notified Body.

Responsibilities

Collaborate with clients and other functions within Intertek to support clients’ medical certification activities.
Support certification programs including ISO 13485, MDSAP, ISO 9001, ANSI/NSF 455 and ISO 22716.
Coordinate efforts between client and Intertek Medical Notified Body as it pertains to MDR/EC certification activities.
Deal with client technical questions, document requests, billing issues, and complaints/disputes.
Process changes that affect medical device certifications (i.e., address, scope, employee count, and jurisdiction changes).
Work with program management, auditors, scheduling, sales, finance, and other functions to ensure consistent and compliant medical certifications.
Manage an external database to ensure timely reporting to regulatory agencies and manage a shared email inbox.