Manager, Regulatory Affairs Job at Stryker, Portage, MI

  • Stryker
  • Portage, MI

Job Description

Stryker seeks an experienced regulatory affairs manager to lead global strategy for the Surgical Technologies business. The role combines strategic planning, team leadership, and cross-functional collaboration in a hybrid position based in Michigan with significant stakeholder interaction.

Responsibilities

  • Lead and develop high-performing regulatory team with clear objectives and performance management
  • Translate evolving regulatory requirements into actionable plans enabling market access
  • Provide strategic regulatory guidance to R&D, Quality, Clinical, Manufacturing, and Commercial teams
  • Oversee regulatory submissions, registrations, agency interactions, inspections, and audits
  • Lead negotiations with global regulatory authorities, notified bodies, and external stakeholders

Requirements

  • Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related scientific field
  • Minimum 6 years experience in medical device, pharmaceutical, biotechnology, or regulated industry
  • Demonstrated experience preparing, reviewing, or overseeing regulatory submissions and authority interactions
  • People management experience or track record leading cross-functional programs
  • Knowledge of FDA, EU, and international regulatory requirements including ISO standards
  • Fluency in English

Compensation: $126,500 - $210,700 USD Annual

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