Katalyst CRO
Senior Regulatory Affairs Specialist - LATAM
Salt Lake City Metropolitan Area – 1 week ago
Responsibilities
Providing regulatory guidance to cross‑functional partners, developing global regulatory strategies for new and modified medical devices.
Assist in the development of regulatory strategies for new products and design changes, ensuring regulatory requirements for target markets are met.
Preparing and submitting regulatory submission documents for U.S. and OUS regulatory filings under minimal supervision (EU and other OUS geographies).
Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements.
Prepare Technical Files/Design Dossiers, Change Notifications, and submissions (e.g., 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, ISO 13485:2016, 21 CFR Part 820, and regulations applicable for MDSAP certification.
Prepare documentation that is complete, accurate, and on time.
Utilize detailed, in‑depth understanding of regulations, interpret regulations, and provide regulatory guidance to product development teams.
Actively participate in defining customer requirements, product claims, and target markets early in the product development lifecycle.
Participate 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 13485, MDR, MHLW, CMDR, and other applicable regulations to ensure all requirements are met.
All other duties as assigned.
Requirements
Bachelor's degree in chemistry, science, or engineering discipline.
4+ years of work experience in regulatory affairs in the medical device, biotech, or pharmaceutical industry.
Experience in regulatory submissions (e.g., writing/developing/preparing/creating submissions for medical devices such as Q‑Submission, 510(k), IDE, PMA, Technical File, Design Dossier).
Regulatory Affairs Certification (RAC) preferred.
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Responsibilities
Providing regulatory guidance to cross‑functional partners, developing global regulatory strategies for new and modified medical devices.
Assist in the development of regulatory strategies for new products and design changes, ensuring regulatory requirements for target markets are met.
Preparing and submitting regulatory submission documents for U.S. and OUS regulatory filings under minimal supervision (EU and other OUS geographies).
Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements.
Prepare Technical Files/Design Dossiers, Change Notifications, and submissions (e.g., 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, ISO 13485:2016, 21 CFR Part 820, and regulations applicable for MDSAP certification.
Prepare documentation that is complete, accurate, and on time.
Utilize detailed, in‑depth understanding of regulations, interpret regulations, and provide regulatory guidance to product development teams.
Actively participate in defining customer requirements, product claims, and target markets early in the product development lifecycle.
Participate 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 13485, MDR, MHLW, CMDR, and other applicable regulations to ensure all requirements are met.
All other duties as assigned.
Requirements
Bachelor's degree in chemistry, science, or engineering discipline.
4+ years of work experience in regulatory affairs in the medical device, biotech, or pharmaceutical industry.
Experience in regulatory submissions (e.g., writing/developing/preparing/creating submissions for medical devices such as Q‑Submission, 510(k), IDE, PMA, Technical File, Design Dossier).
Regulatory Affairs Certification (RAC) preferred.
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