[Hiring] Medical Program Coordinator @Intertek

Role Description

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.

• 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.

This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.

Qualifications

• 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

Requirements

• 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.

Benefits

• Competitive compensation packages
• Medical, dental, vision, life, and disability insurance
• 401(k) with company match
• Generous vacation / sick time (PTO)
• Tuition reimbursement
• And more