Global Regulatory Strategy Lead, MedTech

NAMSA; United States; Remote; USD 102,000 - 198,000; Full time

Job summary

NAMSA seeks an experienced regulatory leader to drive global regulatory strategies for medical devices, IVDs, and related technologies across product development stages. You will serve as the primary regulatory consultant for clients, guiding submissions, interactions with FDA, Health Canada and global regulators, and shaping market access strategies.

You’ll lead cross-functional teams, mentor consultants, and contribute to NAMSA's thought leadership through conferences and publications, with

Qualifications

• 7+ years of medical device regulatory experience with leadership of development programs.
• Advanced degree in science, engineering, business, or related field preferred.
• Prior FDA/regulatory authority or medical device industry experience expected.
• Knowledge of global regulations and quality systems (FDA, EU MDR/IVDR, ISO 13485, MDSAP, etc.).

Responsibilities

• Lead development and execution of global regulatory strategies for devices, IVDs, and combination products.
• Serve as primary regulatory consultant for clients, guiding approvals and market access.
• Prepare, review, and support regulatory submissions with health authorities worldwide.
• Develop regulatory assessments, technical docs, and clinical/non-clinical strategies.
• Lead cross-functional teams and mentor consultants to deliver integrated solutions.
• Provide risk-based regulatory guidance and communicate project risks and timelines.

Skills

Regulatory leadership

Regulatory affairs

Global compliance

Technical writing

Cross-functional teamwork

Regulatory strategy

Education

Master's degree or PhD

Job description

NAMSA seeks an experienced regulatory leader to drive global regulatory strategies for medical devices, IVDs, and related technologies across product development stages. You will serve as the primary regulatory consultant for clients, guiding submissions, interactions with FDA, Health Canada and global regulators, and shaping market access strategies.

You’ll lead cross-functional teams, mentor consultants, and contribute to NAMSA's thought leadership through conferences and publications, with