Associate Manager, Regulatory Affairs (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 an Associate Manager, Regulatory Affairs to join our Acute Care business unit, Hybrid, to be based in Portage, Michigan.

Who we want

• 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.

• 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. 

• Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and cross-functional teams.

What you will do

Leads Global Market Operations Regulatory Affairs Team for the Acute care business unit. Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with global 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

• A minimum of a Bachelor’s Degree (B.S. or B.A.) required; preferably in Science or Engineering.
• A minimum of 7 years of experience within a regulated industry required; preferably in Medical Device.
• A minimum of 3 years of Medical Device Quality or Regulatory Affairs experience required.
• A Master’s Degree or advance degree preferred​.
• A RAC Certification preferred.
• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements required.
• Demonstrated technical knowledge of medical device product line required.
• 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.
• Demonstrated leadership skills.
• Experience mentoring interns and interviewing candidates preferred. 
• Demonstrated ability to coach and develop team members.  
• Demonstrated process improvement and management skills.
• Experience with recruiting employees preferred.
• Experience in managing a team of direct reports including people development preferred.