Careers in MedTech

Job Title

Director International Regulatory Affairs

Company

Stryker

Description

WHAT THE CANIDATE WILL DO:

Leads the international regulatory affairs function.  Responsible for the development of global regulatory strategies for high complexity medical devices intended for global submission. Accountable for ensuring cross functional alignment and support to meet regulatory global requirements. Direct and contribute to initiatives within the organization.  Devotes a significant portion of time to managerial, leadership and employee development responsibilities.

  • Develop and interpret regulatory requirements from global markets, recommend to Regulatory Affairs Management specific activities and resources required to support and execute strategies to further the global growth of the business
  • Represent Stryker in interactions with global health authorities to support the regulatory approval and commercialization efforts in global markets.
  • Ensure that international submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of Stryker’s mission.
  • 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
  • Establishes project priorities, allocates resources and workload
  • Provides technical guidance to team during strategy formulation, submission preparation and interaction with global regulatory bodies.
  • Develops and implements departmental policy and procedures.
  • Provides International Regulatory Affairs training/mentoring to other employees.
  • Oversees preparation and submission of regulatory applications and maintenance of internal regulatory file documentation.
  • Implement regulatory system changes to support evolving regulations and international standards
  • Manage and provide updates for regulatory metrics. Implement appropriate enhancements.
  • Participate in advocacy activities of a more advanced strategic nature

WHAT THE CANDIDATE WILL NEED:

  • Bachelor's degree in a scientific discipline, advanced degree preferred.
  • 10 to 15 years’ experience in a regulated industry required; medical device experience preferred.
  • 8+ years’ experience managing in a regulated industry required; medical device management experience preferred.
  • Industry certifications such as RAC preferred.
  • Strong technical knowledge of medical device products.
  • Experience with global regulations, including experience with global health authorities, e.g., FDA, Health Canada, CE Marking, Japan MHLW/PMDA and China NMPA.
  • Thorough knowledge of FDA, QSR and ISO standards, regulations and requirements.
  • Strong organizational, leadership, interpersonal and influencing skills.
  • Direct management experience required/Exceptional leadership capabilities.

Travel Percentage: 20%

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.

Published
October 13, 2021
Location
Western USA, United States of America
Category
Medtech  
Job Type
Only registered members can apply for jobs.
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