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Job description
Join Stryker's Instruments business as a Regulatory Affairs Specialist and support regulatory activities for products used across a broad portfolio of surgical and medical technologies. In this role, you will help maintain regulatory compliance, support submission activities, and provide regulatory intelligence that enables products to meet global market requirements. This is an excellent opportunity for an early-career professional to develop foundational regulatory affairs expertise while partnering with cross-functional teams in a highly regulated environment.
What You Will Do
- Monitor regulatory requirements, guidance documents, and industry standards across applicable global markets.
- Research and compile regulatory requirements, approval pathways, and compliance information for products and programs.
- Collect, organize, and maintain regulatory intelligence files, submission documentation, and supporting records.
- Assist in preparing regulatory dossiers, pre-submission packages, and submission materials for regulatory agencies.
- Track regulatory submissions and applications under review and provide status updates to stakeholders.
- Maintain records of communications, commitments, and outcomes with regulatory authorities and other stakeholders.
What You Will Need
Required Qualifications
- Bachelor’s degree required. Preferred to be in Engineering, Science, Regulatory Science, or a related technical field.
- Demonstrated ability to work with technical, scientific, or regulated documentation through academic, internship, co-op, or professional experience.
Preferred Qualifications
- Experience supporting regulatory affairs, quality, clinical, research, or compliance activities in a regulated industry.
- Familiarity with medical device, pharmaceutical, biotechnology, or other regulated industry regulations and standards.
USN: $72,500 - $120,900 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
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.
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