Medical Device, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Manager Regulatory Affairs to join our Robotics Division in Mahwah, NJ.
As the center of knowledge for worldwide regulatory strategy for Stryker's Mako (Robotics) Division, the Regulatory Affairs team supports cutting-edge robotic systems globally. The team is an integral partner with Product Development, Software Development, Quality, Legal, Marketing and Operation teams to ensure seamless regulatory input and support throughout the product life-cycle. We focus on the robotic system, associated software applications and the corresponding instruments used for total joint implantation. Become a member of the team leading the way on robotics technology and help bring innovative products to the market.
Who we want
We are seeking energetic, results-driven regulatory professional for exciting, high impact opportunity to work on projects that make a difference in the world.
Results Driven: Thrives on accomplishing tasks and constantly driven to do more.
Strategic: Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.
Focus: Takes direction, follows through, and makes the corrections necessary to stay on track. Prioritizes then acts.
Collaborators: Collaborates and builds relationships with internal and external stakeholders.
Communicators: Articulates well and expresses ideas effectively.
Learners: Great desire to learn and looks to continuously improve.
Teammates: Supports, encourages, and inspires others.
What you will do
As the Manager Regulatory Affairs, you will manage regulatory activities for new and mature products to ensure alignment and compliance with US and global registration requirements as well as with company policies. You will have strategic focus on timely submissions and approvals of pre-market submissions, marketing applications, etc. You will lead and counsel a small regulatory team. Ensure timely preparation of organized and scientifically valid applications. Provide expertise in translating regulatory requirements into practical, workable plans.
Act as a liaison with all regulatory authorities regarding submissions and audits.
Ensure all applicable regulations and standards and changes to these are communicated throughout the organization through company policies, procedures, and training.
Develop regulatory approval strategies to meet business objectives.
Review and approve marketing applications as needed prior to submission to regulatory bodies.
Ensure that all labeling, marketing literature, and internal policies and procedures are reviewed for compliance to regulatory requirements.
Ensure that all changes to products and processes (including additions and deletions) are reviewed for compliance to regulations and significant changes are communicated to the applicable regulatory body prior to implementation.
Participate in the preparation of Regulatory Affairs operating plans and objectives in alignment with company and departmental strategies.
Plan and manage key projects to ensure resources and support are provided as needed and report metrics to upper management.
Remain current with new product development projects to ensure regulatory requirements are considered and appropriate strategies developed.
Recruit, hire, train, manage, develop and motivate Regulatory Affairs staff.
Manage consultants and their contracts for assigned regulatory projects.
Ensure that departmental Standard Operating Procedures (SOP's) are developed, implemented, and maintained.
Review Quality System procedures for regulatory impact.
Prepare and manage budget for the Regulatory Affairs department.
Participate in continuous improvement activity and process re-engineering projects.
Interacts with regulatory agencies.
What you need
A Bachelor’s Degree (B.S or B.A) is required; preferably in a scientific or equivalent technical discipline.
A minimum of 6 years of experience working in Regulatory Affairs.
A minimum of 10 years of experience in a FDA regulated industry.
Previous managerial/supervisory experience.
Regulatory Affairs Certification preferred.
Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.
Demonstrated experience in interacting with FDA review staff and inspectors, Notified Bodies and international reviewers/inspectors.
Demonstrated ability to lead diverse team and team members in remote locations
Internal Number: R412677
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.