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Manager, Global Regulatory Affairs de Cary, IL em Stryker Corporation

Data de Postagem: 6/12/2019

Resumo do Emprego

Descrição do Emprego

Who we want                                            

  • Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.
  • Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
  • Insightful advisors. Managers who lead strategy development and provide guidance to teams
  • Metrics-oriented managers. People who are always tracking important business metrics to ensure projects meet expectations and budget.

What you will do

The Manager, Global Regulatory Affairs establishes a regulatory center of excellence, develops organizational strategies, processes, goals, and metrics to drive measurable improvement in regulatory processes. They are responsible for overseeing the consistency of regulatory processes.

Key areas of responsibility:

  • Drive new approaches to improve the development, review, and oversight of healthcare products.
  • Direct and contribute to initiatives within the organization, with groups engaged in the development of good regulatory practice and policy.
  • Manage day-to-day regulatory processes to ensure issues are appropriately evaluated
  • Establish annual budgets and quarterly forecasts
  • Make 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
  • Implement appropriate enhancements
  • Represent regulatory  processes during internal and external audits
  • Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets
  • Recruit, select, and on-board top talent
  • Develop talent within team to increase performance
  • Actively address performance issues on team
  • Maintain a high level of team engagement
  • Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature

What you need

  • BS in a science, engineering or related Advanced degree preferred
  • Minimum of 9 years experience preferred
  • Master's Degree or equivalent preferred
  • RAC desired
  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
  • Demonstrate technical knowledge of medical device product lines
  • Demonstrated written, verbal, listening, communication, and team-building skills
  • Demonstrated ability to collaborate effectively with and lead cross-functional teams
  • Demonstrated ability to effectively prioritize and manage multiple project workloads
  • Demonstrated experience with trending and analysis reporting
  • Demonstrated process improvement and management skills
  • Experience with recruiting and talent development

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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