Manager, Regulatory Affairs

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, 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 

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

The Manager, Regulatory Affairs is responsible for developing regulatory strategy in the Instruments Division to enable and maintain market access in the United States, Canada, Europe and global regions. Through close partnership with business unit, Marketing, R&D, Clinical, Quality, production and supply teams, the Manager will lead a team who develops and advises on product positioning, product maintenance and exit strategies, among others.

What you will do

• Develops and updates US, global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
• Provides guidance to integrate regulatory considerations into global product entry, maintenance and exit strategies
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
• Provides strategic input and technical guidance on global regulatory requirements to cross-functional teams
• Provides guidance on regulatory strategies and submissions addressing business, marketing, design, labeling, supply and manufacturing changes
• Ensure that submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company mission
• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions
• Represent regulatory processes during internal and external audits
• Participate in internal & external advocacy activities of a strategic nature
• 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
• Manage and provide updates for regulatory metrics. Implement appropriate enhancements
• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets

What you need

• Bachelors in a science, engineering or related Advanced degree.
• Minimum of 9 years’ experience required
• 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
• Demonstrated ability to effectively prioritize and manage multiple project workloads
• Demonstrated experience with trending and analysis reporting

Preferred

• Master's Degree or equivalent
• RAC desired