Senior Regulatory Consultant

🕒 October 1

🌐 United States, Belgium – Remote

🇺🇸 United States – Remote 🇧🇪 Belgium – Remote

💵 $101.6k - $197.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 2%

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NAMSA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1967

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

Healthcare • Manufacturing • Logistics

NAMSA is a global leader in medical device testing and research, offering comprehensive consulting, preclinical research, clinical research, and testing services for medical device and IVD manufacturers worldwide. With a team of over 1,400 specialists and state-of-the-art labs across North America, Europe, and Asia, NAMSA conducts extensive testing to ensure the safety, efficacy, and compliance of medical devices. The company provides strategic consulting on regulatory submissions and market strategies, helping clients navigate complex regulatory landscapes efficiently and effectively. Founded in 1967, NAMSA is trusted by manufacturers to deliver high-quality services from concept to commercialization.

📋 Description

• 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 • Interpret regulatory requirements, assess regulatory impact, and recommend practical, risk-based pathways to market • Manage multiple client engagements simultaneously, ensuring high-quality deliverables, timelines, budgets, and proactive communication of project risks and issues • Support business development activities by engaging with prospective clients, defining project scope, contributing to proposals, estimating effort, and identifying opportunities for additional NAMSA services • Mentor and coach consultants and associates, providing technical leadership and contributing to colleagues' professional development • Contribute to NAMSA's thought leadership through conference presentations, webinars, publications, standards participation, white papers, and other scientific or marketing initiatives • Drive continuous improvement of consulting processes, service delivery, and regulatory best practices • Maintain expert knowledge of global medical device regulations, standards, guidance documents, and industry trends • Travel approximately 5 to 10% of the time

🎯 Requirements

• 7+ years of medical device regulatory experience, including strategic leadership of product development programs • Prior FDA, regulatory authority, or medical device industry experience required • Expertise in one or more areas, including regulatory affairs, clinical strategy, non-clinical testing, engineering, combination products, or IVDs • Strong knowledge of global medical device regulations, standards, and quality systems, including FDA, EU MDR/IVDR, ISO 13485, MDSAP, GCP, GLP, GMP, NMPA, and PMDA • Demonstrated ability to develop regulatory strategies, assess regulatory impact, and support interactions with global regulatory agencies • Strong analytical, problem-solving, communication, writing, and presentation skills • Ability to lead cross-functional teams, manage multiple priorities, and deliver high-quality results within timelines and budgets • Commitment to continuous learning and professional development in emerging regulatory and industry topics • Advanced degree (Master's, PhD, or equivalent) in science, engineering, business, or a related field preferred

🏖️ Benefits

• Professional development and continuous learning opportunities • Mentoring and coaching opportunities • Reasonable accommodations for individuals with disabilities • Equal employment opportunity • Pre-employment background and drug screen processes aligned to local, state, and federal laws

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