高级监管顾问
Senior Regulatory Consultant
NAMSA在行业中开创先河，是全球首家专注于医疗设备材料安全性的独立公司。在1976年美国食品药品监督管理局开始对这类产品进行监管之前，NAMSA就已经开始测试医疗设备。
我们正在塑造行业。NAMSA一直是制定规范我们行业的测试方法的关键贡献者。我们已成为行业的首选供应商。我们在产品开发的每个阶段及之后都为客户提供支持。
加入我们，与一个具备以下特点的组织一起工作：
以激发创新的医疗技术解决方案为愿景，推动全球医疗进步，改善患者生活，并加速客户成功；
以通过我们的人员、专业知识和技术，提供一流的全球医疗技术开发解决方案为使命，坚持我们的核心价值观：
- 在我们所做的每件事中都秉持诚信。
- 提供一流的客户体验。
- 培养优秀人才并提供专业知识。
- 以敏捷的方式响应并提供及时的结果。
- 拥抱协作、多元的观点和想法。
薪酬目标：
150,000美元
职位描述：
• 领导医疗设备、体外诊断、组合产品及相关技术在全球范围内的监管策略开发与执行，覆盖产品开发的所有阶段。
• 作为客户的首要监管顾问，提供科学、技术和战略指导，以支持监管审批、市场准入和商业化目标。
• 准备、审查并支持监管提交文件及与卫生当局和符合性评估机构的互动，包括FDA、加拿大卫生部及其他全球监管机构。
• 开发和审查监管评估、技术文件、临床和非临床策略、测试计划及支持性证据包。
• 领导跨职能项目团队，并与临床、质量、生物统计、报销和实验室专家合作，交付整合的客户解决方案。
• 通过解读监管要求、评估监管影响并推荐实际的、基于风险的上市路径，成为客户的可信赖顾问。
• 同时管理多个客户项目，确保高质量交付成果，遵守时间表和预算，并主动沟通项目风险和问题。
• 通过与潜在客户接触，支持业务发展活动，
查看英文原文
NAMSA 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.
We 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.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
- Act with integrity in everything we do.
- Provide best-in-class customer experiences.
- Develop superior talent and deliver expertise.
- Respond with agility and provide timely results.
- Embrace collaboration, diverse perspectives and ideas.
Compensation Target:
$150,000.00Job 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.
•Act as a trusted advisor to clients by interpreting regulatory requirements, assessing regulatory impact, and recommending practical, risk-based pathways to market.
•Manage multiple client engagements simultaneously, ensuring high-quality deliverables, adherence to timelines and 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 other associates, providing technical leadership and contributing to the professional development of colleagues.
•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 across the organization.
•Maintain expert knowledge of global medical device regulations, standards, guidance documents, and industry trends to ensure clients receive current and effective regulatory advice.Qualifications & Technical Competencies:
- 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 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 (FDA, EU MDR/IVDR, ISO 13485, MDSAP, GCP, GLP, GMP, NMPA, PMDA, etc.).
- 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.
Working Conditions:
- The 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.
- While 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 and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and the ability to adjust focus.
- Extensive use of a computer keyboard.
- Travel approximately 5 to 10% of the time.
The compensation grade range for this position is:
$101,600.00 - $197,500.00 -
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Originally posted on Himalayas