Staff Regulatory Affairs Specialist, Mako and Enabling Technologies
工作灵活性：远程管理人员监管事务专家，马科和启动技术 （远程）加入 Stryker 的奥尔多科技业务并支持包括机器人，导航，成像，软件和资本设备技术的投资组合。在这个角色中，你将提供整个产品生命周期中的监管领导力，与跨职能团队合作，支持全球产品开发，监管提交，市场访问以及在美国和国际市场持续遵守监管。工作灵活性 · 制定和执行新产品，产品变化和生命周期管理活动的全球监管战略。·参与产品开发团队以确保美国，欧洲和国际监管要求在所有发展阶段都被纳入。·评估医疗器械和相关技术的产品分类，监管途径以及司法要求。· 作者并提交监管文件，包括 FDA 提交，国际注册和支持产品批准所需的文件。·审查质量，临床前和临床文档以确保提交准备和符合法规。· 合作与全球监管机构支持注册，市场扩张和后期监管活动。· 与监管当局和通知机构进行交流，包括准备答案，提交文件和代理通信。· 对产品标签，营销材料以及产品要求的遵守情况进行审查，并向年级监管团队成员提供监管流程和最佳实践指导。你需要什么资格 ·工程学士学位，科学，监管事务或相关领域。· 在 FDA 规范的行业至少4年的经验。· 监管事务经验至少3年。· 准备产品批准的监管文件经验；优先资格 · 监控事务认证 (RAC) 和/或相关领域士学位。· 支持 II 类和/或 III 级医疗器械的经验。· 授权 FDA510 ((k) 提交文件经验。• 与监管机构和通知机构直接互动的经验
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Work Flexibility: RemoteStaff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)
Join Stryker’s Ortho Tech Business and support a portfolio that spans robotics, navigation, imaging, software, and capital equipment technologies. In this role, you will provide regulatory leadership throughout the product lifecycle, partnering with cross-functional teams to support global product development, regulatory submissions, market access, and ongoing regulatory compliance across U.S. and international markets.
Work Flexibility:
This is a remote position, with a preference for candidates located in the U.S. Eastern Time Zone
What You Will Do
- Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities.
- Participate in product development teams to ensure U.S., European, and international regulatory requirements are incorporated throughout all development phases.
- Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies.
- Author and submit regulatory filings, including FDA submissions, international registrations, and supporting documentation required for product approvals.
- Review quality, preclinical, and clinical documentation to ensure submission readiness and regulatory compliance.
- Partner with global regulatory affiliates to support registrations, market expansions, and post-market regulatory activities.
- Lead interactions with regulatory authorities and notified bodies, including preparation of responses, submissions, and agency communications.
- Review product labeling, marketing materials, and product claims for compliance with applicable regulatory requirements and mentor junior regulatory team members on regulatory processes and best practices.
What You Will Need
Required Qualifications
- Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or a related field.
- Minimum 4 years of experience in an FDA-regulated industry.
- Minimum 3 years of Regulatory Affairs experience.
- Experience preparing regulatory submissions for product approvals.
Preferred Qualifications
- Regulatory Affairs Certification (RAC) and/or Master’s degree in Regulatory Affairs or a related field.
- Experience supporting Class II and/or Class III medical devices.
- Experience authoring FDA 510(k) submissions.
- Experience interacting directly with regulatory agencies and notified bodies.
United States of America Pay Ranges:
- Puerto Rico: $77,700 - $129,500 USD Annual
- USN: $95,700 - $159,500 USD Annual
- US5: $100,500 - $167,500 USD Annual
- US10: $105,300 - $175,500 USD Annual
- US15: $110,100 - $183,400 USD Annual
- US20: $114,800 - $191,400 USD Annual
- US30: $124,400 - $207,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: NoneStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.Originally posted on Himalayas