Global Regulatory Lead, Medical Devices & IVDs

NAMSA; Diest; On-site; EUR 91,000 - 177,000; Full time

Job summary

NAMSA is seeking a senior regulatory leader to shape and drive global regulatory strategies for medical devices, in vitro diagnostics, and combination products across all development stages.

You will serve as the primary regulatory consultant for clients, preparing submissions and guiding interactions with FDA, Health Canada, and other regulators while leading cross-functional teams and mentoring colleagues.

Qualifications

• 7+ years of medical device regulatory experience, including strategic leadership of product development programs.
• Advanced degree (Master's, PhD, or equivalent) in science, engineering, business, or a related field preferred.
• Prior FDA, regulatory authority, or medical device industry experience required.
• Expertise in regulatory affairs, clinical strategy, non-clinical testing, engineering, or IVDs.
• Strong knowledge of global medical device regulations, standards, quality systems (FDA, EU MDR/IVDR, ISO 13485, MDSAP, GCP, GLP, GMP, NMPA, PMDA, etc.).

Responsibilities

• Lead the development and execution of global regulatory strategies for medical devices, in vitro diagnostics, 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, including FDA, Health Canada, and other global regulators.
• Develop and review regulatory assessments, technical documentation, clinical and preclinical strategies, testing plans, and supporting evidence packages.
• Lead cross-functional project teams and collaborate with clinical, quality, biostatistics, reimbursement, and laboratory experts to deliver integrated client solutions.

Skills

Regulatory strategy

Regulatory leadership

Global regulatory knowledge

Cross-functional leadership

Regulatory consulting

Regulatory submissions

Education

Advanced degree (Masters/PhD)

Job description

NAMSA is seeking a senior regulatory leader to shape and drive global regulatory strategies for medical devices, in vitro diagnostics, and combination products across all development stages.

You will serve as the primary regulatory consultant for clients, preparing submissions and guiding interactions with FDA, Health Canada, and other regulators while leading cross-functional teams and mentoring colleagues.