Regulatory Affairs Operations Manager - 30642BR - EN in Fremont, CA at Stryker Corporation

Date Posted: 5/23/2018

Job Snapshot

Job Description

Who we want
Challengers. People who seek out the hard projects and work to find just the right solutions.
Teammates. Partners who listen to ideas, share thoughts and work together to move the business forward.
Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.
Customer-oriented achievers. RA professional with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.
Game changers. Persistent, business minded Regulatory Operations Manager who will stop at nothing to live out Stryker’s mission to make healthcare better.

What you will do
As the RA Operations Manager for Stryker Neurovascular, you lead a team with a mission to deliver best-in-class service to internal and external stakeholders. You collaborate confidently within and outside of your division, set direction and initiate process improvements projects supporting submission e-publishing for FDA, Canada, and EU markets. You use your RA and project management skills and expertise to streamline processes, provide expert advice to corporate stakeholders on IT / ERP platforms that will transform RA product release and life-cycle management globally. You lead the creation of RA metrics and leading-indicators that will inform and guide divisional leadership to improved sell-on-approval timelines for product lines changing the lives of patients who suffer stroke in 70+ markets across the globe.

The company
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at .

The Division
Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke, and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters.

Our mission
Together with our customers, we are driven to make healthcare better.

Job Requirements

What you need
  • A minimum of 10 years+ experience within medical device or other regulated industry, with a preference for cross-functional experience
  • 3 years+ demonstrated people management; project management experience desired in at least one discipline (RA, R&D, Operations, PMO, etc.)
  • Demonstrated ability to manage global cross-functional projects to successful completion

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