Senior Regulatory Affairs Specialist; Hybrid

We are currently seeking a Senior Regulatory Affairs Specialist to join our Acute Care business unit based hybrid three days per week in Portage, Michigan
.

As the Senior Regulatory Affairs Specialist
, you will support Stryker’s Acute Care portfolio for our global market. You will be responsible for maintaining global market access by analyzing the impact of device modifications and emerging regulatory intelligence. You will help identify global regulatory requirements to support new product development. You will enable global product sales in new markets by liaising with global Stryker teams to execute registrations in accordance with health authority requirements.

• Evaluate device modifications and take appropriate action to ensure global product compliance.

• Support new product development in submitting registrations and subsequently support registration renewals in global markets.

• Analyze and advise on the impact of emerging regulatory intelligence.

• Provide regulatory input and technical guidance on global regulatory requirements to product development teams.

• Determine requirements and options for global regulatory submissions, approval pathways, and compliance activities.

• Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines in global markets.

• Participate in preparation and execution of audit required to enable of maintain market access.

• Identify the need for new regulatory procedures, SOPs, and participate in development and implementation.

Required

• Bachelor's degree

• 2+ years of experience in an FDA or highly regulated industry

• 2+ years of full-time work experience in Regulatory Affairs and/or Quality Systems

• Demonstrated ability to analyze and resolve non‑routine regulatory issues using independent judgment.

• Ability to manage multiple priorities and adapt to changing regulatory requirements.

Preferred

• Bachelor's degree (B.S. or B.A.) in Science, Engineering, or a related discipline;
  Experience supporting Class II and/or Class III medical devices

• Experience authoring or supporting FDA 510(k) submissions

• Prior experience interacting directly with regulatory agencies

• Experience authoring global regulatory submissions for product approval

• RAC certification or an advanced degree (e.g., Master’s in Regulatory Affairs)