Want (Remote) Principal Regulatory Affairs Specialist, Software in USA

Job title: (Remote) Principal Regulatory Affairs Specialist, Software

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 Principal Regulatory Affairs Specialist 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



This position will work in close collaboration with the Digital Robotics & Engineering (DREs) Commercial Division partners to provide knowledge and guidance to new product development teams. Possesses and applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures 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 platforms.

• Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy.


• Participates in advocacy activities of a more advanced strategic nature.


• Develops and updates global, regional, and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies in collaboration with Commercial Division RA.


• Provides guidance to integrate regulatory considerations into global product entry and exit strategy.


• Identifies and consults on regulatory pathways for initial product designs and provides input to internal stakeholders.


• Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.


• Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles.


• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations.


• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy).


• Partners with Commercial Divisions in negotiating with regulatory authorities on complex issues throughout the product lifecycle.


• Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.


• Identifies the need for and collaborates 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.


• Develops and manages programs that train stakeholders on current and new regulatory requirements focused in the areas of Digital SW products and AI.to ensure enterprise-wide compliance.


• Provides strategic input and technical guidance on global regulatory requirements to new product development teams.


• Evaluates risks of product and clinical safety issues specific to Digital SW products and AI during clinical phases and recommends regulatory solutions.


• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions.


• Reviews and provides input to Commercial Division RA regarding proposals to regulatory authorities on regulatory paths and clinical plans.


• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.


• Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships.


• Provides regulatory guidance on strategy for proposed product claims/labeling.


• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.


• Manages electronic (eCTD) and paper registration development.


• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions as appropriate with guidance from Commercial Division RA.


• Participates in key negotiations and interactions with regulatory authorities during all stages of the development and review process in coordination with and at the request of Commercial Division partners.


• Participates on cross-functional teams for interactions with regulatory authorities including panel/advisory committees.

What you need

• A Bachelor’s degree required; in Engineering, Biological Sciences or equivalent focus preferred.


• A minimum of 9 years of working in a FDA regulated industry required.


• A minimum of 7 years of Regulatory Affairs experience required.


• Previous experience authoring 510(k)s and other regulatory submissions required.


• Experience interacting with regulatory agencies required.


• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.


• Strong leadership skills.


• Demonstrated success in management of global regulatory strategy and submission activities required.


• Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations).


• Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements.


• Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment.


• Strong interpersonal, written and oral communication skills.


• Good time and project management skills with the ability to multi-task.

• $109,500 - $179,500 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: $109500 - 179500 per year

Location: USA

Apply Job!