Senior Regulatory Affairs Specialist; Hybrid

Overview

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
.

What You Will Do

• Support Stryer’s Acute Care portfolio for our global market by maintaining global market access and analyzing the impact of device modifications and emerging regulatory intelligence.
• Identify global regulatory requirements to support new product development.
• 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 audits required to enable and maintain market access.
• Identify the need for new regulatory procedures, SOPs, and participate in development and implementation.

• 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

• 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)

Health benefits include:
Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include:
Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Stryker offers innovative products and services in Med Surg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements, employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.