Manager, Regulatory Affairs, (Hybrid) - Michigan, Portage 1941 Stryker Way

Work Flexibility: Hybrid

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, Orthopaedics 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 www.stryker.com

Who we want

• Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
• Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.
• Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
• Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

We are currently seeking a Manager, Regulatory Affairs to join our Medical Division. This is a hybrid role based in Portage, Michigan.

What you will do

The Manager, Regulatory Affairs (RA) works with a high level of autonomy to oversee the regulatory process for products requiring governmental approval, including filing necessary applications and handling government interactions to bring medical devices to market and ensure ongoing compliance while managing a regulatory team. In this role, you will;

• 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
• Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature

What you need

• BS in a science, engineering or related required
• Minimum of 9 years’ experience required
• 3 years of supervisory experience preferred
• Master's Degree or equivalent preferred
• RAC desired

Travel Percentage: None

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.