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The Regulatory Affairs Specialist will support regulatory activities, maintain compliance, and provide intelligence for orthopedic products. They will also assist in preparing regulatory dossiers and managing submission documentation for global markets.
Candidates must hold a Bachelor's degree, preferably in Engineering, Science, or Regulatory Science, with 3-7 years of relevant experience. Familiarity with medical device or regulated industry standards is highly preferred.
Join Stryker's Ortho Tech Division as a Regulatory Affairs Specialist and support regulatory activities for products used across a broad portfolio of Orthopedic Instruments. 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.
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.
Coordinate meeting logistics and develop supporting materials for discussions with regulatory agencies and internal teams.
Organize and support the review of preclinical, clinical, quality, and technical documentation used to meet regulatory requirements.
Bachelor’s degree required. Preferred to be in Engineering, Science, Regulatory Science, or a related technical field with 3-7 years of work experience.
Demonstrated ability to work with technical, scientific, or regulated documentation through academic, internship, co-op, or professional experience.
Master’s degree in Regulatory Science or a related field.
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.
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer 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. More information is available at stryker.com and careers.stryker.com. Facts: ● 2024 Sales: $22.6 billion ● Industry: Medical Instruments & Supplies ● Employees: 53,000 worldwide ● 44+ Manufacturing and R&D Locations Worldwide ● $1.5 billion spent on research and development in 2024 ● ~14,200 patents owned globally in 2024 ● Products sold in ~75 countries ● Fortune 500 Company ● 9 consecutive years as one a World's Best Workplace Stryker’s social media community guidelines: https://www.stryker.com/content/m/legal/social-media-community-guidelines/en/index.html Notice Regarding Employee Conduct on Facebook/LinkedIn Meta/LinkedIn does not permit employers to verify or validate “employees” in the (META: “Works at” LinkedIn: “Experience”) section of users’ profiles. Please be aware that the views expressed by individuals on their personal accounts and do not necessarily represent the views of our company. If you encounter any issues with a person claiming to be our employee, we recommend using the “Report Profile” feature. If you’d like to report concerns to our Ethics Hotline, you may do so at: https://app.convercent.com/en-us/LandingPage/b6bb4e84-9fcb-ea11-a974-000d3ab9f296
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