REGULATORY SPECIALIST

3T Medical Systems; United States; Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

3T Medical Systems seeks a Regulatory Specialist to lead regulatory compliance and market access across our medical device portfolios. You will collaborate with Quality, Engineering, Operations, and Commercial teams to prepare submissions, maintain documentation, and ensure global compliance throughout the product lifecycle.

The role focuses on U.S. FDA 510(k) submissions, international filings, and ongoing regulatory surveillance, with emphasis on risk management and life-cycle compliance.

Qualifications

• Bachelor’s degree in a scientific, engineering, or healthcare discipline.
• 3+ years in medical device Regulatory Affairs.
• Solid working knowledge of FDA regulations, ISO 13485, and risk management principles.
• Strong technical writing, document management, eQMS proficiency, and cross-functional collaboration.
• Nice to Have experience with Health Canada, MDSAP, active medical devices, accessories, or IVDs.

Responsabilités

• Prepare and coordinate U.S. FDA 510(k), pre-submissions, and international regulatory filings.
• Manage registrations, renewals, and establishment listings.
• Support international licensing, export/Free Sale certificates, and distributor coordination.
• Assess design, software, and manufacturing changes for regulatory impact; review IFUs, labels, and promotional materials.
• Maintain regulatory files, technical dossiers, risk management, and design verification/validation records.
• Support ISO 13485, FDA QSR, and MDSAP compliance; assist with complaints, adverse events, and recalls.

Connaissances

Technical writing

Document management

eQMS proficiency

Cross-functional collaboration

Formation

Bachelor’s degree in science/engineering/healthcare

Description du poste

We are looking for a Regulatory Specialist to lead regulatory compliance and market access for our medical device portfolios across 3T Medical Systems and Enterix, Inc. In this role, you will work closely with Quality, Engineering, Operations, and Commercial teams to prepare submissions, maintain technical documentation, and ensure global compliance throughout the product lifecycle.

Key Responsibilities

• Submissions & Registrations: Prepare and coordinate U.S. (FDA 510(k), pre-submissions) and international regulatory filings, renewals, and establishment listings.
• Global Market Access: Support international licensing, export/Free Sale certificates, and collaboration with foreign representatives and distributors.
• Change Control & Labeling: Assess design, software, and manufacturing changes for regulatory impact; review IFUs, labels, and promotional materials.
• Technical Documentation: Maintain regulatory files, technical dossiers, risk management, and design verification/validation records.
• Quality System & Postmarket: Support ISO 13485, FDA QSR, and MDSAP compliance, while assisting with complaint assessments, adverse events, and recalls.

Requirements:

• Education: Bachelor’s degree in a scientific, engineering, or healthcare discipline (or equivalent experience).
• Experience: 3+ years in medical device Regulatory Affairs.
• Core Expertise: Solid working knowledge of FDA regulations, ISO 13485, and risk management principles.
• Key Skills: Strong technical writing, document management, eQMS proficiency, and cross-functional collaboration.
• Nice to Have: Experience with Health Canada, MDSAP, active medical devices, accessories, or IVDs.