Senior Regulatory Consultant

pNAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.
S. Food and Drug Administration started regulating such products in 1976. /ppWe are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. /ppCome and work for an organization with the: /ph3Vision /h3pto inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the /ph3Mission /h3pto deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core /ph3Values /h3ulliAct with integrity in everything we do. /liliProvide best-in-class customer experiences. /liliDevelop superior talent and deliver expertise. /liliRespond with agility and provide timely results. /liliEmbrace collaboration, diverse perspectives and ideas. /li /ulp$150,000.00 /ph3Job Description /h3ulliLead 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. /liliServe as the primary regulatory consultant for clients, providing scientific, technical, and strategic guidance to support regulatory approvals, market access, and commercialization objectives. /liliPrepare, review, and support regulatory submissions and interactions with health authorities and conformity assessment bodies, including FDA, Health Canada, and other global regulators. /liliDevelop and review regulatory assessments, technical documentation, clinical and preclinical strategies, testing plans, and supporting evidence packages. /liliLead cross-functional project teams and collaborate with clinical, quality, biostatistics, reimbursement, and laboratory experts to deliver integrated client solutions. /liliAct as a trusted advisor to clients by interpreting regulatory requirements, assessing regulatory impact, and recommending practical, risk-based pathways to market. /liliManage multiple client engagements simultaneously, ensuring high-quality deliverables, adherence to timelines and budgets, and proactive communication of project risks and issues. /liliSupport business development activities by engaging with prospective clients, defining project scope, contributing to proposals, estimating effort, and identifying opportunities for additional NAMSA services. /liliMentor and coach consultants and other associates, providing technical leadership and contributing to the professional development of colleagues. /liliContribute to NAMSA's thought leadership through conference presentations, webinars, publications, standards participation, white papers, and other scientific or marketing initiatives. /liliDrive continuous improvement of consulting processes, service delivery, and regulatory best practices across the organization. /liliMaintain expert knowledge of global medical device regulations, standards, guidance documents, and industry trends to ensure clients receive current and effective regulatory advice. /li /ulh3Qualifications Technical Competencies /h3ulli7+ years of medical device regulatory experience, including strategic leadership of product development programs. /liliAdvanced degree (Master's, PhD, or equivalent) in science, engineering, business, or a related field preferred. /liliPrior FDA, regulatory authority, or medical device industry experience required. /liliExpertise in one or more areas, including regulatory affairs, clinical strategy, non-clinical testing, engineering, combination products, or IVDs. /liliStrong knowledge of global medical device regulations, standards, and quality systems (FDA, EU MDR/IVDR, ISO 13485, MDSAP, GCP, GLP, GMP, NMPA, PMDA, etc.). /liliDemonstrated ability to develop regulatory strategies, assess regulatory impact, and support interactions with global regulatory agencies. /liliStrong analytical, problem-solving, communication, writing, and presentation skills. /liliAbility to lead cross-functional teams, manage multiple priorities, and deliver high-quality results within timelines and budgets. /liliCommitment to continuous learning and professional development in emerging regulatory and industry topics. /li /ulh3Working Conditions /h3ulliThe physical demands described here must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. /liliWhile performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, sit, use hands to finger, handle, or feel, and reach with hands