Manager, Regulatory Affairs, (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 Instruments 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