Regulatory Affairs Specialist - 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).

• Provie 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.

Requirements:

• Direct experience with preparing Pre-Submission and interfacing with FDA personnel.

• Excellent knowledge and experience with global medical device regulatory requirements, design control, and product registration.

• Working knowledge of product development process.

• Ability to assess the changes to marketed products and their impact on product registration.

• Ability to identify, research, analyze technical documentation, and interpret governmental regulations.

• Excellent oral and written communication skills.

• Serve as regulatory liaison and work in cross-functional product development team.

• Capable of handling multiple tasks/projects and managing priorities accordingly.

• Effective interpersonal/communication skills.

• Works well under pressure in a dynamic timeline-driven environment.

• Extensive experience with MS Word and EXCEL.

• Regulatory Affairs Certification (RAC) preferred.