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Staff Regulatory Affairs Specialist

Company: Stryker Group
Location: Redmond
Posted on: August 6, 2022

Job Description:

Why RA/QA at Stryker? Are you interested in working for a global company where you can work across functions and on awide-varietyof 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. Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting Our benefitsinclude 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.Stryker is seeking to hire a Staff Regulatory Affairs Specialist to join our Medical Division to be based either remotely in the Pacific or Central time zone or hybrid locally in Redmond, Washington.Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.What you will doAs the Staff Regulatory Affairs Specialist, you will engage in regulatory strategy and operations through technical and management skills. You will engage in technical and scientific regulatory activities, to include strong project management, writing, coordination, and execution of regulatory documentation and related activities. You will utilize skills in areas such as: regulatory pathways, risk-benefit analysis, internal/external communication and collaboration, submission, registration, obtaining approval, documentation, compliance, post-market surveillance/vigilance, and/or distribution.
    • Develop regulatory strategy and communicate with responsible personnel on regulatory requirements for clinical studies and/or marketing applications, evaluation of regulatory filing strategies, and assessment of resulting documentation for compliant with regulatory and corporate requirements.
    • Coordinate and execute pre-approval compliance activities and the preparation, review, and submission of regulatory filings.
    • Monitor impact of changing regulations, develop and implement plans for continued compliance.
    • Assist in the development and implementation of systems and processes in order to maintain and enhance regulatory compliance.
    • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
    • Participate in internal/external audits.
    • Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation.
    • Ensure compliance with product post-marketing approval requirements.
    • Review and approve advertising/promotional items, product labeling, and product claims to ensure compliance with regulatory requirements.
    • Identify product-associated problems and develop proposals for solutions.
    • Assist in the development and implementation of systems and processes in order to maintain and enhance regulatory compliance.
    • Provide regulatory input to support compliant resolution of production issues.
    • Participate in internal/external audits.
    • Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation.What you need
      • Bachelor's degree required. Bachelor's degree in Engineering or Science preferred.
      • 5+ years of experience in an FDA regulated industry.
      • 2+ years in Regulatory Affairs position, preferably in the Medical Device Industry.
      • PMA, 510K, Technical File experience preferredKnow someone at Stryker? Be sure to have them submit you as a referralprior to applyingfor this position. Learn more about ouremployee referral programat 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 one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting

Keywords: Stryker Group, Redmond , Staff Regulatory Affairs Specialist, Other , Redmond, Washington

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