Senior Regulatory Affairs Specialist - Springfield Massachusetts

Company: VirtualVocations
Location: Springfield, Massachusetts
Posted On: 11/21/2024

A company is looking for a Senior Regulatory Affairs Specialist to manage the lifecycle of OEM products and ensure regulatory compliance.



Key Responsibilities

Coordinate and prepare document packages for regulatory submissions and internal audits
Lead the compilation of materials for submissions, license renewals, and annual registrations
Recommend changes for regulatory compliance in labeling, manufacturing, and clinical protocols


Required Qualifications

Bachelor's degree with 4+ years of experience in regulatory affairs or an advanced degree with 2+ years of experience
4+ years of medical device regulatory affairs experience is preferred
Experience with global regulatory pathways such as 510(k) and EU MDR
Familiarity with ISO standards, particularly ISO 13485, and Quality Management Systems (QMS)
Local to CO and willing to work in a hybrid capacity is a plus More...

Register an account with us and set up job agents! We'll email you immediately when jobs like this are posted on our site.