Manager, Divisional Regulatory Compliance in Mahwah, NJ at Stryker Corporation

Date Posted: 10/22/2018

Job Snapshot

Job Description

Who we want

Challengers.  People who seek out the hard projects and work to find optimal 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. Representatives with an unparalleled work ethic, customer-focused attitude, and subject matter expertise, who bring value to their partnerships.

Game changers. Persistent, business minded Regulatory professional who will put customers first and live Stryker’s mission to make healthcare better.

What you will do

As the Manager of Regulatory Compliance for Stryker Joint Replacement, you lead a divisional, multi-site team with a mission to ensure strict containment of non-conforming product in all manufacturing locations around the world.  You collaborate confidently within and outside of your division to assess potential hazards and harms in a Health Hazard assessment setting. You set direction and lead the regulatory decision-making process for potential field actions, interfacing with company leadership in mission critical decisions.  You will interface with FDA, Canada, EU, and other global health authorities as you navigate the decision-making process.  You use your Quality and Regulatory skills and expertise to protect our customers and ensure we conform to all regulatory requirements around the world.  You lead a team of cross-functional subject matter experts through emerging quality issues, to containment, assessment, and communication phases of potential regulatory actions.

What you need

  • 10+ years+ experience within medical device or other regulated industry. Cross-functional experience preferred
  • 3 years+ demonstrated people management; project management experience desired in at least one discipline (RA, R&D, Operations, PMO, etc.)
  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
  • Demonstrated ability to manage cross-functional projects to successful completion

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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