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Senior Regulatory Affairs Specialist

1 month ago

Portage, Michigan, United States Stryker Full time
Job Summary

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Stryker. As a key member of our Acute Care business unit, you will be responsible for maintaining global market access by analyzing the impact of device modifications and emerging regulatory intelligence.

Key Responsibilities:

  • Evaluate device modifications and ensure global product compliance.
  • Support new product development by submitting registrations and renewals in global markets.
  • Analyze and advise on emerging regulatory intelligence.
  • Provide regulatory input and technical guidance to product development teams.
  • Determine requirements and options for global regulatory submissions and compliance activities.

Requirements:

  • Bachelor's Degree in Science, Engineering, or equivalent focus.
  • Minimum 2 years of experience in an FDA or highly regulated industry.
  • Minimum 1-2 years in a Regulatory Affairs role.
  • Previous experience with Class II/III medical devices preferred.
  • Excellent analytical and writing skills.
  • Excellent interpersonal, written, and oral communication skills.

About Stryker:

Stryker is a global leader in medical technologies, driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine that help improve patient and healthcare outcomes. Alongside our customers, we impact over 150 million patients annually.