Regulatory Affairs Manager (Remote) (R445110)
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. 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
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 Regulatory Affairs Manager to join our Endoscopy division to be based in San Jose, CA or remotely anywhere in the United States.
Who we want
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.
Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.
Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.
What you will do
As the Regulatory Affairs Manager, you will be responsible to prepare complex submissions and/or presentations to regulatory agencies and for any related communications. You will also be responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. You will establish project priorities, ensure resources are available and balanced and formulate long range project strategies.
Manage development and implementation of regulatory strategies for new and modified devices through preparation of submissions and interface with FDA, notified body and other reviewing international authorities, and internal team members.
Lead business unit in revision and/or development of processes/ procedures for, and implementation of, new or revised regulatory requirements based on either change in the business or regulatory requirements.
Develop personnel through daily interactions and coaching of staff, provide guidance to staff in technical and Regulatory matters and in effective business partnering with Marketing, R&D, and Clinical.
Serve as representative of the regulatory affairs function to improve awareness, visibility and communication on regulatory requirements to support company goals and priorities.
Responsible for support of the internal and external audit programs required for compliance to domestic and international regulations & standards.
What you need
A minimum of a Bachelor’s degree (B.S. or B.A.) required; preferably in engineering or life sciences.
A minimum of 9 years of experience in an FDA regulated industry required; preferably with medical devices.
A minimum of 7 years of Medical Device Regulatory Affairs experience required.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
Experience authoring regulatory submissions for product approval and interacting with regulatory agencies required.
Overall understanding of global medical device regulations and direct experience with the following types of submissions associated with US and EU Medicals Devices: 510(k) and EU Technical Documents required.
Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment.
Strong organizational, leadership, interpersonal and influencing skills.
Good time and project management skills with the ability to multi-task.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.