Remote Global Regulatory Lead – Medical Devices

North American Science Associates, Inc.; Diest; Hybrid; EUR 90,000 - 176,000; Full time

Job summary

NAMSA invites a Senior Regulatory Consultant to join a global MedTech specialist team. This remote-friendly role supports regulators and clients across multiple jurisdictions, including FDA and EU MDR/IVDR, as a trusted regulatory advisor.

You will lead regulatory strategies, mentor associates, and contribute to thought leadership while advancing safe, compliant medical devices and diagnostics worldwide.

Qualifications

• 7+ years of medical device regulatory experience.
• Advanced degree in science, engineering, business, or related field preferred.
• Prior FDA, regulatory authority, or medical device industry experience.
• Expertise in regulatory affairs, clinical strategy, non-clinical testing, engineering, combination products, or IVDs.
• Strong knowledge of global medical device regulations, standards, and quality systems.
• Strong analytical, problem-solving, communication, writing, and presentation skills.
• Ability to lead cross-functional teams, manage multiple priorities, and deliver high-quality results.

Responsibilities

• Lead the development and execution of global regulatory strategies for medical devices, IVDs, combination products, and related technologies across all stages of product development.
• Serve as the primary regulatory consultant for clients, providing scientific, technical, and strategic guidance to support regulatory approvals, market access, and commercialization objectives.
• Prepare, review, and support regulatory submissions and interactions with health authorities and conformity assessment bodies.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory affairs

FDA/Regulatory authority experience

Global medical device regulations

Clinical strategy

Non-clinical testing

Engineering

IVDs

Analytical skills

Communication skills

Writing skills

Presentation skills

Education

Master's/PhD in science/engineering/business

Job description

NAMSA invites a Senior Regulatory Consultant to join a global MedTech specialist team. This remote-friendly role supports regulators and clients across multiple jurisdictions, including FDA and EU MDR/IVDR, as a trusted regulatory advisor.

You will lead regulatory strategies, mentor associates, and contribute to thought leadership while advancing safe, compliant medical devices and diagnostics worldwide.