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Job Details


Stryker

Staff Regulatory Affairs Specialist (R447818)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Washington, United States

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 stryker.com


Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Regulatory Affairs Specialist to join our Medical Division to be in Redmond, WA.

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.
  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • 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 do

As 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

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering, Legal, or Regulatory or related​ discipline required.
  • A minimum of 5 years of experience in an FDA regulated industry.
  • A minimum of 2 years in a Medical Device Regulatory Affairs role.
  • RAC certification or Advance Degree (Master in Regulatory Affairs) preferred​.
  • Competent with Microsoft Office (Outlook, Excel, Word, etc.).
  • Must possess excellent oral and written communication skills.
  • Must thrive in a team environment, build strong relationships and demonstrate leadership capabilities.
  • Excellent interpersonal communication skills specially relating to people, conflict, and stress management.
  • A passion for continuous improvement and demonstrated problem solving skills.
  • A passion for quality and procedural compliance.
  • Excellent time management skills with the ability to use judgment effectively.
  • Previous experience supporting submissions to the FDA.
  • Ability to understand and explain detailed regulatory compliance programs and/or issues.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.
  • Ability to communicate and network with regulatory personnel to obtain relevant information.
  • Ability to negotiate internally and externally with FDA.
  • Excellent analytical and writing skills.

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.