Regulatory Affairs Specialist
4 days ago
Responsibilities: Providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified medical devices. Assist in the development of the regulatory strategies for new products and design changes - ensuring regulatory requirements for target markets are met. Preparing and submitting regulatory submission documents for US and OUS regulatory filings under minimal supervision for the EU and supporting outside of US (OUS) geographies. Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements. Prepare Technical Files /Design Dossier, Change Notifications, and Submissions ( Documentary Audits under MDD/ MDR). Provide guidance and direction to ensure international product registration/licensing requirements are addressed and met before commercial release to maintain international product registrations. Responsible for ensuring compliance with all relevant quality system regulations, including EU MDR Regulation, ISO :, CFR Part , and the Regulations applicable for MDSAP certification. Prepare documentation that is complete, accurate, and on time. Utilizing detailed, in-depth understanding of regulations, interprets regulations, and provides regulatory guidance to product development teams. Actively participates in defining customer requirements, product claims, and target markets early in the product development lifecycle. Participates in audits and inspections of the company and its quality systems. Review marketing materials, go-to-market strategies, and other commercialization activities as required to ensure continued compliance with established product clearances; lead the development of the regulatory strategy for new claims and indications. Support domestic and international field corrective actions and adverse event reporting. Create and update departmental standard operating procedures (SOPs). Perform all activities in compliance with the Quality System, ISO , MDR, MHLW, CMDR, and all other applicable regulations to ensure all requirements are met. All other duties as assigned. Requirements: Bachelor's degree in chemistry, scientific or engineering discipline. + years of work experience in regulatory affairs in medical device, biotech, or pharmaceutical industry. Experience in regulatory submissions ( writing/developing/preparing/creating submissions for medical devices (Q-Submission, (k), IDE, PMA, Technical File, Design Dossier). Regulatory Affairs Certification (RAC) preferred.
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Regulatory Affairs Specialist
3 weeks ago
Salt Lake City, United States Utah Staffing Full timeRegulatory Affairs SpecialistAn RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates) through...
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Regulatory Affairs Specialist
5 days ago
Salt Lake City, UT, United States Biomerieux Full timeDescription Position Summary: An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates)...
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Regulatory Affairs Specialist
2 weeks ago
Salt Lake City, United States bioMerieux Inc. Full timeDescription Position Summary:An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates) through...
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Regulatory Affairs Specialist
7 days ago
Salt Lake City, UT, United States bioMerieux Inc. Full timeDescription Position Summary: An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates)...
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Regulatory Affairs Specialist
3 days ago
Salt Lake City, UT, United States bioMerieux Inc. Full timeDescription Position Summary: An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates)...
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Regulatory Affairs Specialist
5 days ago
Salt Lake City, UT, United States bioMerieux Inc. Full timeDescription Position Summary: An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates)...
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Regulatory Affairs Specialist
3 days ago
Salt Lake City, UT, United States bioMérieux Full timeDescriptionPosition Summary: An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates) through...
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Staff Specialist, Regulatory Affairs
5 days ago
Salt Lake City, UT, United States Becton , Dickinson and Company Full timeJob Description Summary This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. This position participates on cross-functional teams, leads the development of global regulatory strategies, authors regulatory submissions, leads interactions with regulatory agencies/notified bodies,...
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Staff Specialist, Regulatory Affairs
4 days ago
Salt Lake City, UT, United States Becton , Dickinson and Company Full timeJob Description Summary This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. This position participates on cross-functional teams, leads the development of global regulatory strategies, authors regulatory submissions, leads interactions with regulatory agencies/notified bodies,...
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Staff Specialist, Regulatory Affairs
2 weeks ago
Salt Lake City, United States BD Full timeDescription We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to...
