Staff Regulatory Affairs Specialist

Stryker Corporation • Portage, MI

45d • Hybrid

About The Position

We are seeking a Staff Regulatory Affairs Specialist to join our Medical Division - Acute Care in Portage, MI (Hybrid).

As a Staff Regulatory Affairs Specialist, you will support Stryker's global Acute Care portfolio by maintaining market access and ensuring compliance with evolving regulatory requirements. You will assess device changes, monitor emerging regulatory intelligence, and lead regulatory activities related to wireless technologies. Your work will guide the development, approval, and compliance of innovative medical devices that incorporate wireless communication.

Requirements

• Bachelor's degree (B.S. or B.A.) required, preferably in Engineering, Science, or related field.
• 4+ years of experience in a regulated industry required, preferably with medical devices.
• Previous experience in Pre- or Post-Market Regulatory, Clinical, Quality, or Engineering.

Nice To Haves

• RAC certification or advanced degree (e.g., Master's in Regulatory Affairs).
• General understanding of FDA, EU, and international medical device regulations.

Responsibilities

• Evaluate device modifications and implement actions to maintain global product compliance.
• Analyze emerging regulatory intelligence and advise on potential impact to market access.
• Provide regulatory input and technical guidance to product development teams for global requirements.
• Determine requirements and options for regulatory submissions, approval pathways, and compliance activities.
• Prepare and submit regulatory submissions in alignment with global regulations and guidelines.
• Participate in audits to enable or maintain market access across international markets.
• Identify gaps and contribute to development and implementation of new regulatory procedures and SOPs.
• Support wireless technology compliance within medical devices to meet global regulatory standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 5,001-10,000 employees