Regulatory Affairs Specialist
Job Description
Join Stryker as a Regulatory Affairs Specialist in Portage, MI supporting Instruments – Surgical Technologies. This role will support regulatory activities for the Neptune Waste Management System, ensuring continued market access, compliance, and lifecycle management across global markets. You will partner with cross-functional teams to evaluate product changes, maintain regulatory approvals, and support strategic initiatives that enable ongoing commercialization, refurbishment, and expansion efforts.
What you will do
- Assess regulatory intelligence and summarize implications for local, regional, and global regulatory strategies.
- Evaluate product and process changes for regulatory impact across the device lifecycle, including updates, enhancements, and maintenance activities.
- Identify regulatory risks and propose mitigation plans throughout the product lifecycle.
- Partner with cross-functional teams (R&D, Quality, Marketing) to ensure alignment of regulatory requirements and claims strategy.
- Prepare, review, and support submission of regulatory filings for product changes, global registrations, and lifecycle management activities.
- Monitor regulatory submissions and communicate status updates to internal stakeholders and regulatory authorities.
- Review marketing and promotional materials to ensure compliance and alignment with approved regulatory claims.
- Support development and maintenance of a centralized claims library to enable compliant and efficient marketing updates.
- Support state licensing and other regulatory compliance activities as needed.
What you will need
- Required:
- Bachelor’s degree required. Preferred to be in Engineering, Science, or related field.
- Minimum 0 years of experience in regulatory affairs.
- Preferred:
- 2+ years of experience in regulatory affairs preferred.
- Master’s degree in Regulatory Science.
- Regulatory Affairs Certification (RAC).
- Demonstrated experience (academic, internship, or co-op) supporting regulatory documentation, submissions, or compliance activities in a regulated environment.
- Experience interacting with regulatory authorities (e.g., FDA, EU Competent Authorities).
- Experience interpreting and applying regulatory requirements across product lifecycle stages.
Pay
$72,500 - $120,900 USD Annual
Benefits
- 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.
Contact Information
To learn more about Stryker's employee benefits, click here: US Stryker employee benefits.
About Stryker
Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics 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.