Manager, Regulatory Affairs (Allendale, NJ OR Leesburg, VA) in Leesburg, VA at Stryker Corporation

Date Posted: 6/29/2019

Job Snapshot

Job Description

Who we want 

  • 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.
  • Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.
  • Insightful advisors. Managers who lead strategy development and provide guidance to teams
  • 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 a Manager, Regulatory Affairs supporting Stryker’s Spine division, you will establish a regulatory center of excellence, develop organizational strategies, processes, goals, and metrics to drive measurable improvement in regulatory processes. You will oversee consistency of regulatory processes, drive new approaches to improve the development, review, and oversight of healthcare products and direct and contribute to initiatives within the organization, with groups engaged in the development of good regulatory practice and policy.

Key Areas of Responsibility May Include:

  • Manage day-to-day regulatory processes to ensure issues are appropriately evaluated
  • Establish annual budgets and quarterly forecasts to ensure necessary changes with appropriate management involvement
  • Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met
  • Serve as Subject Matter Expert for regulatory processes
  • Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations
  • Establish standard process to ensure appropriate resolution and management of the responsible task owner
  • Chair meetings required to drive closure of regulatory issues
  • Manage and provide updates for regulatory metrics and implement appropriate enhancements
  • Represent regulatory processes during internal and external audits
  • Define targets, KPIs, performance objectives, etc. for individuals within functional roles, and manage direct reports to meet or exceed these targets
  • Develop talent within team to increase performance and actively address performance issues on team
  • Maintain a high level of team engagement
  • Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature

What you need

  • Bachelor’s degree in a science, engineering or related
  • 9+ years experience preferred
  • RAC desired
  • Master's Degree or equivalent preferred
  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
  • Demonstrate technical knowledge of medical device product lines preferred
  • Demonstrated ability to collaborate effectively with and lead cross-functional teams
  • Demonstrated process improvement, leadership and management skills
  • Experience with recruiting, people development and the ability to influence across an organization

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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