Senior Manager, Regulatory Affairs

Work Flexibility: Hybrid or Onsite We are currently seeking a Senior Manager, Regulatory Affairs to join our Joint Replacement Division to be based hybrid in Mahwah, NJ. Who we want 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. 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. Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision. Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. What you will do As the Senior Manager, Regulatory Affairs, you will provide leadership and guidance to integrate regulatory considerations into global product continuity and exit strategy. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time zones and cultures to achieve market access in alignment with global regulatory requirements. Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy Leads advocacy activities of a more advanced and global strategic nature Provides guidance to integrate regulatory considerations into global product continuity and exit strategy Assesses all requirements and potential obstacles for continued 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 renewal and post approval strategies and approaches based on changing regulations Negotiates 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 continued market access and distribution Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Provides strategic input and technical guidance on global regulatory requirements to product life cycle management team Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans for legacy devices 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 Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees Manage day-to-day regulatory processes to ensure issues are appropriately evaluated Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met Serve as Subject Matter Expert for regulatory processes 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 Chair meetings required to drive closure of regulatory issues Manage and provide updates for regulatory metrics. Implement appropriate enhancements Represent regulatory processes during internal and external audits Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets Recruit, select, and on-board top talent Develop talent within team to increase performance. Actively address performance issues on team Maintain a high level of team engagement Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature Education / Work Experience: BS in a science, engineering or related Advanced degree preferred Minimum of 10 years’ experience preferred Master's Degree or equivalent preferred RAC desired Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements Demonstrate technical knowledge of medical device product lines Demonstrated written, verbal, listening, communication, and team-building skills Demonstrated ability to collaborate effectively with and lead cross-functional teams 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. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.