Associate Manager, Regulatory Affairs, Us Market Compliance (Hybrid)

Work Flexibility: Hybrid
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 anAssociate Manager, Regulatory Compliance, US Market, to join our Instruments Division based Hybrid in Portage, Michigan.
Who we want

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• 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.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• 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.

What you will do
This role is responsible for coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes.

• Responsible for regulatory compliance.
• Responsible for leading and managing a group of Regulatory professionals to ensure regulatory compliance by driving implementation of selected regulatory requirements at the local, state, or federal/regulatory agency levels.
• Lead teams to support regulatory processes for market access of products.
• Manage budget, if appropriate.
• May lead the development of new systems and procedures.
• Plans, conducts, and supervises assignments.
• Reviews progress and evaluate results.
• Support continuous improvement activities.
• 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 technical audit/nature.

What you need

• BS required; focus in Engineering, Science, or related Advanced degree preferred.
• Minimum 7 years' experience required; 3 years supervisory preferred.
• Prior divisional or site experience 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.
• Demonstrated ability to effectively prioritize and manage multiple project workloads.
• Demonstrated experience with trending and analysis reporting.
• Demonstrated leadership skills.
• Demonstrated process improvement and management skills.
• Subject matter expert for the regulatory and Stryker-business requirements of their area of ownership.
• Effective communicator and consensus-builder.
• Proven ability to implement large-scale projects on a broad scale.

Travel Percentage: 20%
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.