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Senior Regulatory Affairs Specialist
Location:
Toms River, NJ
Description:
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
Company:
Virtualvocations
Posted:
November 16 on TopUSAJobs
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More About this Listing: Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist is a Business Opportunities Regulatory Affairs Specialist Job at Virtualvocations located in Toms River NJ. Find other listings like Senior Regulatory Affairs Specialist by searching Oodle for Business Opportunities Regulatory Affairs Specialist Jobs.
Senior Regulatory Affairs Specialist is a Business Opportunities Regulatory Affairs Specialist Job at Virtualvocations located in Toms River NJ. Find other listings like Senior Regulatory Affairs Specialist by searching Oodle for Business Opportunities Regulatory Affairs Specialist Jobs.