Why RA/QA at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; healthcare; insurance benefits; retirement programs; stock based plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

We are currently seeking a Senior Manager, Regulatory Affairs to join our Joint Replacement Division to be based in Mahwah, NJ, Maryland, or Pennsylvania in a hybrid work environment.

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.

• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

As the Senior Manager, Regulatory Affairs, you will provide leadership and coordination of the Joint Replacement divisions’ global regulatory strategies, submission preparation and approvals for new product launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time zones and cultures to achieve market access in alignment with global regulatory requirements.

• Oversee development, communication and implementation of regulatory strategies for new product development projects in alignment with Stryker business objectives.

• Manage the team to support R&D projects, developing robust regulatory strategies and submissions for market access of new products.

• Manage the Patient-Specific Solutions regulatory affairs function to achieve timely approvals of custom devices via custom and compassionate use pathways.

• Utilize resource management tools to plan and manage key projects, ensuring resources and support are provided as needed and report metrics to upper management.

• Lead communications with health care authorities (e.g. FDA and EU Notified Bodies) and direct health authority interactions with internal teams.

• Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.

• Work collaboratively with cross-functional partners and lead project teams, as appropriate, to resolve issues and meet business objectives.

• Ensure quality and robustness of submissions prior to sending them to regulatory bodies.

• Ensure labeling, marketing literature and training materials are reviewed for compliance to regulatory requirements.

• Ensure that changes to products and processes (including additions and deletions) are reviewed for compliance to regulatory requirements.

• Oversee and participate in the preparation of Regulatory Affairs operating plans and objectives in alignment with company and departmental strategies.

• Recruit, hire, train, manage, develop and motivate Regulatory Affairs staff.

• Ensure that departmental Standard Operating Procedures (SOP's) are developed, implemented, and maintained.

• Review Quality System procedures for regulatory impact.

• Prepare and manage annual budget and quarterly forecasts for the Regulatory Affairs department.

• Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure goals and strategies are met.

• Serve as Subject Matter Expert for regulatory processes.

• Manage and provide updates for regulatory metrics.

• 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.

What you need

• A minimum of a Bachelor's Degree in Engineering, Science or relatable degree required.

• A Masters Degree or RAC(s) preferred.

• A minimum of 12 years of experience in an FDA regulated industry required; preferably in Medical Devices.

• A minimum of 5 years experience in a supervisory role required.

• Demonstrated 510(k), PMA organization, preparation, and review experience preferred.

• Demonstrated ability to provide guidance and direction to geographically dispersed, international staff.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com