Senior Quality Regulatory Affairs Specialist (Option to Work Remote) (R449197)
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
We are currently seeking a Senior Quality Regulatory Assurance Specialist to join our Post-Market Surveillance team in Redmond, WA.
Who we want
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of medical device reports.
Self-directed initiators. People who take ownership of their work to drive productivity, change, and outcomes.
Collaborative partners. People who build and leverage cross-functional relationships to ensure accuracy and compliance in all documentation of complaint investigations.
Dedicated achievers. People who thrive in a fast-paced environment and deliver quality results.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
What you will do
- Assures post-market regulatory requirements are met (e.g. required reports, supplemental submissions and other post-marketing commitments)
- Supports all necessary reporting activities related to the complaint handling process
- Interacts with device related agencies on vigilance reports and incidents globally
- Drives reportability recommendations for the post-market surveillance team
- Supports internal and external audits
- Reviews and approves complaint investigations
- Provides input on internal systems and methods to maintain regulatory compliance and support post-market surveillance
- Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
- Supports nonconformance and corrective and preventive action activities for regulatory reporting process optimizations
What you need
- BS in Engineering, Science, or equivalent work experience
- Minimum 2 years relevant experience
- Prior experience with Class III Medical Device Reporting preferred
Knowledge / Competencies:
- Knowledge of defibrillator products preferred
- Knowledge of 21 CFR Part 820, Quality System Regulations
- Knowledge of 21 CFR Part 803, Medical Device Reporting
- Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA Statute
- Knowledge of the Medical Device Directive (MDD)
- Knowledge of Canadian Medical Device Regulation (CMDR)
- Strong analytical skills
- Strong communication skills; oral and written
- High level of computer proficiency
- Work from home optional, position also open to fully remote applicants
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