Regulatory Affairs Specialist (Hybrid)

About Stryker Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named the #5 World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com Why regulatory affairs/quality assurance at Stryker? Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities. If you are interested in working at one of the World's Best Workplaces, apply now! Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: We are currently seeking a Regulatory Affairs Specialist to join our Upper Extremities Division to be based in Bloomington, Minnesota.You will need to live within commuting distance to our Bloomington, Minnesota office. This role is a Hybrid position which includes working in the office 2-3 days a week, but you will have the flexibility to work from home on the other days.Are you interested in working for a global company where you can work across functions and on a wide variety of projects? As a member of Stryker's Regulatory Affair's team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities. If you are interested in working at one of the World's Best Workplaces, apply now!Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: WHAT YOU WILL DO: As the Regulatory Affair's Specialist, you will be responsible for supporting the preparation of US and International regulatory submissions. You will directly support the development and maintenance of submissions, documentation, labeling and procedures. Identifies information sources and resources for local, regional, and global regulations Collects, organizes, and maintains files on local, regional, and global regulatory intelligence and other related information Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) Provides information used to evaluate proposed products for regulatory classification and jurisdiction Research requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities Assists in the development of regulatory procedures and SOPs Collects and organizes information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations Organizes materials from preclinical and clinical studies for review and assists in the review process Compiles and organizes materials for pre-submission reports and communications Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies Tracks the status of applications under regulatory review and provides updates to the regulatory team Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders WHAT YOU NEED: A Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus is required. 0+ years relevant work experience required. 1+ years Regulatory Affairs experience preferred. 1+ years Medical Device experience preferred. General understanding of product development process and design control preferred. General understanding of regulations applicable to the conduct of clinical trials preferred. Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) preferred. Technical writing experience preferred. Ability to read and understand regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents. Ability to effectively present information to other employees, management, and regulatory agencies preferred Proficient in Microsoft Office Suite, including Word, Excel and PowerPoint preferred. Our benefits Our total rewards offering varies by country but often includes bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards - not to mention various social and recreational activities. Know someone at Stryker? Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at