Related content
Why join Stryker?
Job description
Stryker is hiring a Senior Regulatory Affairs Specialist for our Instruments/Neurosurgical division. This is a hybrid position based two to three days per week onsite in Portage, MI.
As the Senior Regulatory Affairs Specialist, you will work across functions to develop regulatory strategies, prepare submissions, maintain product registrations, and interpret evolving global regulatory requirements. The role provides exposure to regulatory authorities, market access activities, product changes, audits, and post-market compliance.
What You Will Do
- Develop and implement regulatory strategies and submission plans based on product classification, market requirements, approval pathways, and applicable regulations.
- Prepare and submit regulatory documentation, including product registrations, annual licenses, listings, supplemental dossiers, and notifiable changes to applicable regulatory authorities.
- Evaluate product and manufacturing changes for regulatory impact and recommend submission, approval, and compliance requirements throughout the product lifecycle.
- Maintain post-market regulatory compliance by supporting safety reporting, product recalls, post-market commitments, required reports, and communications with regulatory authorities.
- Review advertising, promotional materials, product labeling, and instructions for use to verify alignment with applicable regulatory requirements.
- Monitor regulatory intelligence and assess emerging requirements, risks, and market access considerations to inform local, regional, and global regulatory strategies.
- Partner with Product Development, Quality, Marketing, and other stakeholders to integrate regulatory requirements into product development, commercialization, and lifecycle activities.
- Support regulatory inspections and audits, develop regulatory procedures and standard operating procedures, and train stakeholders on new or changing regulatory requirements.
What You Need
Required
- Bachelor’s degree in Engineering, Science, Life Sciences, or a related discipline
- Minimum 2 years of experience in Regulatory Affairs or a related regulatory discipline within a regulated industry.
- Experience preparing, coordinating, or executing regulatory submissions and related documentation.
- Experience interpreting and applying regulatory requirements to product development, commercialization, or post-market activities.
Preferred
- Master's degree in Regulatory Science or Regulatory Affairs Certification (RAC)
- Experience in the medical device industry
- Experience supporting product registrations, regulatory submissions, product changes, or post-market regulatory activities across multiple markets
- Experience interacting with regulatory authorities or supporting regulatory inspections and audits
- USN: $83,300 - $138,800 USD Annual
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. Click here to learn more about: US Stryker employee benefits 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.
Apply Now