A company is looking for a Senior Regulatory Affairs Specialist to manage the lifecycle of OEM products and ensure regulatory compliance.
Key ResponsibilitiesCoordinate and prepare document packages for regulatory submissions and internal auditsLead the compilation of materials for submissions, license renewals, and annual registrationsRecommend changes for regulatory compliance in labeling, manufacturing, and clinical protocolsRequired QualificationsBachelor's degree with 4+ years of experience in regulatory affairs or an advanced degree with 2+ years of experience4+ years of medical device regulatory affairs experience is preferredExperience with global regulatory pathways such as 510(k) and EU MDRFamiliarity 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
Senior Regulatory Affairs Specialist
A company is looking for a Senior Regulatory Affairs Specialist to manage the lifecycle of OEM products and ensure regulatory compliance. ...
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The Senior Regulatory Affairs Specialist plays a vital role in ensuring compliance with global regulatory standards for medical devices. The ideal candidate will possess strong regulatory expertise, with a focus on technical documentation and regulatory compliance. Minimum of 5 years’ experience in ...
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Senior Public Affairs Specialist - ( 24000421 ). Stantec's Water group is looking to hire a Public Affairs Specialist to join our team working on Safe and Affordable Funding for Equity and Resilience (SAFER) Drinking Water projects throughout California. This is a role for an experienced Public Rela...
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