Urgently Need Senior Manager, Regulatory Affairs, Software (Remote) in Fort Lauderdale, FL

Job Description

Job title: Senior Manager, Regulatory Affairs, Software (Remote)

Company: Stryker

Job description: Work Flexibility: Remote or Hybrid or Onsite

Stryker is one of the world’s leading medical technology companies and together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at

We are currently seeking a Senior Manager, Regulatory Affairs to join our Digital Robotics & Engineering (DRE) team, this position is Remote or Hybrid in the USA. Preference to Eastern and Central states to align with global partners.

Who we want

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

Develop a regulatory center of excellence, develop organizational strategies, processes, goals, and metrics to drive measurable improvement in regulatory outcomes. Oversee consistency of regulatory processes. Drive new approaches to improve the development, review, and oversight of healthcare products focused in the areas of DREs Digital portfolio. This includes but is not limited to Clinical Decision Support Software, Extended Reality (XR), and Artificial Intelligence / Machine Learning (AI/ML), and cloud and other connected devices and technology platforms. Direct and contribute to initiatives within the organization with groups engaged in the development of good regulatory practice and policy. This position will work in close collaboration with DREs Commercial Division partners to provide knowledge and guidance to new product development teams. Manage regulatory processes for DRE to ensure issues are appropriately evaluated and resolved.

• Recruit, select, and on-board top talent. Develop talent within team to increase performance.
• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
• Communicate and collaborate with DRE and Commercial Division partner RAQA, R&D, and Marketing departments to ensure NPD goals and strategies are met.
• Interact with groups within the organization, including global regulatory team, governmental affairs, division SME, GPO, H&S, and GQO, depending on topics.
• Identify the need for and collaborate with Commercial Division RA teams to manage the development and execution of new regulatory procedures and standard operating procedures focused in the areas of Digital SW products and AI.
• Partner with Commercial Divisions in negotiating with regulatory authorities on complex issues throughout the product lifecycle.
• Review and provide input to Commercial Division RA regarding proposals to regulatory authorities on regulatory paths and clinical plans.
• Serve as DRE Division Process Owner and Subject Matter Expert for regulatory processes and develop strategic plan to implement appropriate enhancements.
• Accountable for local process and training implementation including all Divisional business units and acquisitions in scope.
• Updates the GPO and/or PMO on divisional deliverables and progress.
• Ensures the global initiatives in their area are communicated and understood by divisional stakeholders.
• Communicate to leadership and stakeholders throughout levels at their division/site.
• Serves as an active member of hub and spoke teams (led by GPOs) to establish, implement, and maintain Global Regulatory and Quality processes, tools and documents supporting our Global QMS.
• Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.
• Establish standard process to ensure appropriate resolution and management of the responsible task owner.
• Ability to initiate and lead advocacy conversation in using leadership and analytical skills to structure conversation to reach consensus as a group and clearly communicate Stryker’s position. Available to engage with Trade Association working group(s).
• Manage and provide updates for regulatory metrics.
• Represent regulatory processes during internal and external audits.
• Maintain a high level of team engagement.
• Establish annual budgets and quarterly forecasts

What you need

• Minimum 12 years of experience, 7 in regulatory affairs, medical device, biotechnology or contract research industry, acting in a regulatory affairs or technical role involved with new product development and product submission; preference for exposure to sustaining product in the marketplace.
• A Master’s Degree or advance degree preferred?.
• Demonstrated ability to develop direct reports, encourages a team dynamic, and promotes a healthy work/life balance.
• Demonstrated ability to coordinate and prioritize workload in collaboration with cross-functional colleagues.
• US RAC preferred.
• Experience with FDA regulations and 510(k) submissions with a preference for experience with MDD/MDR and MHLW/PMDA regulations and compliance as well as Health Canada.
• Regulatory experience in medical devices with Class I, II required.
• Significant 510(k) and Technical File/Design Dossier preparation, review, and submission experience highly preferred.
• Thorough knowledge of FDA, QSR and ISO standards, regulations and requirements; experience in the front room for audits
• Ability to understand, interpret, and explain complex development details and regulations to non-experts.
• Must be able to effectively interact with internal and external customers to obtain accurate information.
• Must possess the ability to handle different projects with competing deadlines.

$109,500 – $232,900 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives. Benefits (including but not limited to health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10%

Stryker 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.

Expected salary:

Location: Fort Lauderdale, FL

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