Senior Manager, Regulatory Affairs in Redmond, WA at Stryker Corporation

发布日期: 9/28/2019



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 Senior Manager, Regulatory Affairs to join our Medical Division to be based in Redmond, WA.

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.
  • Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.
  • 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.
  • 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 Senior Manager, Regulatory Affairs, you will develop, implement and maintain the Regulatory Affairs systems. You will ensure compliance to FDA, CE Mark, and International regulations. You will lead the regulatory team to ensure regulatory compliance by completing the appropriate filings and documentation pertaining to FDA and CE Mark product approval and product registration as required by regulatory agencies. You will build a strong team that works in partnership with the business to drive a collaborative, compliant culture.

  • Responsible for the management and supervision of Regulatory Affairs department personnel including defining targets, KPIs, performance objectives, etc. and ensure direct reports to meet or exceed these targets.
  • Establish annual budgets and resource plans to support the business.
  • Recruit, select, and on-board top talent
  • Directs all regulatory activities to ensure new product development and product sustainment meet regulatory requirements and customer quality expectations.
  • Provide FDA and CE Mark regulatory training and leadership for Class I, II, and III Medical Devices
  • Manage divisional relationship with FDA and EU Notified Body through direct engagement with the agency
  • Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met
  • Assures that the global regulatory requirements are implemented and maintained.
  • Defines, specifies, and/or approves of the implementation of standards, methods, and procedures for ensuring products designed and sold meet regulatory testing and engineering requirements of the markets in which they are sold.
  • Provide guidance on mandated or industry changes that impact divisional regulatory compliance
  • Communicate gaps with regulations and standards to appropriate levels within the organization.
  • Represent regulatory processes during internal and external audits
  • Monitors and assess changing regulatory requirements, trends, and policies for impact to the business.
  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal procedures to assure compliance, and then assists the organization in driving implementation.
  • Responsible for the selection, supervision, development and objective setting for teams consisting of managers, individual contributors and clerical/technical staff.
  • Works with regulatory affairs and quality assurance teams across the Corporation to achieve Stryker’s mission, vision and objectives.
  • Supports new business opportunities and acquisitions.

What you need

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering or related​ discipline required.
  • A minimum of 12 years of experience in a Quality/Regulatory environment required.
  • A minimum of 5 years in a Medical Device Regulatory Affairs role.
  • Previous demonstrated managerial/supervisory/leadership experience required.
  • A Master’s Degree or advance degree preferred​.
  • An electrical or mechanical engineering degree preferred.
  • Experience with FDA and CE Mark submission process and regulatory strategy for Class III medical devices; including PMA required.
  • Must possess excellent communication, strategic thinking, analytical and negotiation skills.
  • Functional skills including personnel selection, financial systems, organization structure protocol, interdepartmental interface, interdivisional interface and P&L management.
  • RAPS certification preferred.

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.