Job Information
Stryker Manager, Regulatory Affairs in Portage, Michigan
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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
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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.