Regulatory Affairs Specialist

Company : Katalyst Healthcares & Life Sciences

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 (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 Regulation, ISO 13485:2016, 21 CFR Part 820, 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 13485, 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.
• 4+ years of work experience in regulatory affairs in medical device, biotech, or pharmaceutical industry.
• Experience in regulatory submissions (i.e. writing/developing/preparing/creating submissions for medical devices (Q-Submission, 510(k), IDE, PMA, Technical File, Design Dossier).
• Regulatory Affairs Certification (RAC) preferred.

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