Senior Quality and Regulatory Consultant
这是一个遥远的位置。你是谁：从第一原则开始，你思考质量和监管战略，将客户的风险和业务目标转化为一个合适的计划而不是通用游戏册。让你有动力的是确定项目或客户的质量系统需要什么，而不是在自动驾驶上运行相同的过程。你很舒服地工作于一系列任务，而不是只嵌入其中。你专注于客户和解决方案，与那些质量/监管退伍军人一样自然地与客户合作。你会做些什么？•领导评估和启动的承诺，以直接向客户提供有关其自身质量管理系统，风险管理过程和监管战略的建议。•在发现时，与交付团队合作确定项目级质量和监管策略，确定适用的监管要求以及该项目的成功需要什么。•与客户进行质量协议，并作为设计转让的最终质量和法规审查员，确认项目质量计划和医疗器械文件转移之前是完整的和可辩护的。•与交付经理合作，将质量和监管战略与项目范围，预算和时间表相结合，寻找满足客户需求的解决方案。•建立和发展奥尔多冈纳评估和启动实践，并追踪 SAMD,AI/ML 以及数字卫生监管的方向。报告给 VP,质量 &监管 （功能/技术）;分配到交付经纪人 （项目日常）在交付团队所在的地方上的任务上 要求：在相关技术，质量或监管领域或相等的经验中。•6年以上医疗设备或 SAMD 质量/监管咨询或领导工作经验，包括直接顾客咨询工作。•深入，实践流利性与 ISO 13485,IEC 62304,ISO 14971及相关标准，在美国 FDA 和欧盟 MDR 框架内工作 （优先考虑额外的地理位置）. •真正经验范围分析和定义质量和监管战略
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This is a remote position.
Who you are:
You think about quality and regulatory strategy from first principles, translating a client's risk and business goals into a right-sized plan rather than a generic playbook. What energizes you is the strategic puzzle of scoping what a project or a client's quality system needs, not running the same process on autopilot. You're comfortable working across a portfolio of engagements rather than being embedded in just one. You're client-focused and solutions-oriented, working just as naturally with clients who are quality/regulatory veterans as with those who are newer to the space.
What You'll Do:
•Lead assessment and enablement engagements end to end, advising clients directly on their own quality management system, risk management process, and regulatory strategy.
•Define project-level quality and regulatory strategy at discovery, in collaboration with the delivery team, determining applicable regulatory requirements and what the project needs to succeed.
•Own quality agreements with clients, and serve as the final quality and regulatory reviewer at design transfer, confirming the project's quality plan and medical device file are complete and defensible before transfer.
•Partner with the Delivery Manager to reconcile quality and regulatory strategy with project scope, budget, and timeline, finding solutions that satisfy client needs on both fronts.
•Build and grow Orthogonal's assessment and enablement practice, and track where SaMD, AI/ML, and digital health regulation is heading.
Reports to:VP, Quality & Regulatory (functional/technical); assigned Delivery Manager (project day-to-day) on engagements where a delivery team is in place
Escalates to VP, Quality & Regulatory when:a quality or regulatory strategy question can't be reconciled with project scope, budget, or timeline through direct collaboration with the Delivery Manager, or a methodology decision affects engagements beyond one client.
Requirements
Requirements (candidate must have this experience):
•BS or MS in a relevant technical, quality, or regulatory field, or equivalent experience.
•6+ years of experience in medical device or SaMD quality/regulatory consulting or leadership, including direct client advisory work.
•Deep, practical fluency with ISO 13485, IEC 62304, ISO 14971, and related standards, working within both US FDA and EU MDR frameworks (additional geographies preferred).
•Real experience scoping and defining quality and regulatory strategy for a project or organization, not just executing an existing plan, and comfortable working across a portfolio of engagements at a strategic level rather than being embedded full-time in one.
•Strong written and verbal communicator, confident negotiating quality agreements and advising client executives directly.
Preferences (you’d be a strong fit if…)
•Preferred: Experience building or growing an assessment, enablement, or advisory service line.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.We are unable to hire outside of the U.S. for this role.
Benefits
- Salary range: $130,000-$185,000
- Location: Remote within the U.S.
- Medical, dental, and vision insurance options
- 401k & 401k matching options
- Company-provided technology
- PTO + 10 company holidays
- Strong work-life balance
- Flexible work schedule within regular business hours
Originally posted on Himalayas