Regulatory Affairs Specialist

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 :