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Regulatory Affairs Director

2 months ago

San Jose, California, United States Stryker Group Full time
Job Summary

Stryker Group, a leading medical technology company, is seeking a highly skilled Regulatory Affairs Director to join our Endoscopy business unit. As a key strategist, you will be responsible for developing and delivering regulatory strategies to bring Stryker's best-in-class Visualization products to market in the United States, Canada, and Europe.

Key Responsibilities:
  • Develop and advise on product positioning, product entry and exit strategies, and regulatory requirements for complex and critical products.
  • Lead the development and execution of good regulatory practices and policy.
  • Manage negotiations with regulatory authorities on complex issues throughout the product lifecycle.
  • Interface and establish working relationships with multiple government and non-government organizations impacting market access and distribution.
  • Lead efforts to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs.
  • Develop and implement regulatory system changes to support evolving regulations and international standards.
  • Provide strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activities.
  • Ensure that pre-market submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations.
Requirements:
  • Bachelor's degree in engineering or other relevant field of study.
  • Master's Degree or equivalent preferred.
  • Minimum of 10 years' experience required.
  • RAC desired.
Competencies:
  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.
  • Demonstrated expertise in regulatory systems in a regulated environment.
  • Demonstrated project management skills.
  • Demonstrated verbal, written, and interpersonal communication skills.
  • Demonstrated ability to work in a team environment, interact effectively with management from other functions.
  • Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets.
Compensation:

Salary: $189,400 – $321,000 plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.