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Director, Post Market Regulatory Affairs & Quality Assurance

Invuity

This is a Full-time position in Tempe, AZ posted October 31, 2021.

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!

Stryker’s Sustainability Solutions (SSS) is the leading provider of reprocessing and remanufacturing services for single-use devices.

Reprocessing of singe-use medical devices (SUDs) is the practice of inspecting, cleaning, function testing, sterilizing and packaging so that they can be clinically and safely used again.

This role will require proximity to our Tempe, AZ office in order to be onsite 2 – 3 days a week with flexibility to work from home on the other days.

Who We Want:

  • Business-oriented evaluators.

    People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.

  • Strategic thinkers.

    People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

  • Collaborative partners.

    People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

What Will You Do:

Leads the global post-market regulatory and quality functions.

Responsible for ensuring exceptional customer product experience is maintained by monitoring and continuously improving product quality in addition to complying with all global post-market standards and regulatory requirements.

Is responsible for managing the complaint intake, global adverse event reporting, and product field action teams and processes and identifying required changes in response to changing regulations or continuous improvement initiatives.

Manages multiple labs and technicians to support new product development and post-market complaint investigation activities.

Interfaces with regulatory agencies when executing product field actions or when additional information is required for adverse events.

ensure functional excellence.

  • Develop and interpret regulatory requirements from global markets, recommend to Regulatory Affairs and Quality Assurance (RAQA) Management specific activities and resources required to support and execute strategies to further the global growth of the business
  • Represent Stryker in interactions with external organizations including the FDA and other global health authorities, sponsors, and other organizations; serve as a primary Regulatory contact during all post-market activities and work with Stryker organizations to support the regulatory approval and commercialization efforts in global markets.
  • Lead the team of post-market quality engineers to investigate complex complaints across all product lines and from all global geographies in addition to monitoring and improving product quality through continuous improvement projects.
  • Lead the supervisory organization for complaint intake technicians, new product development lab technicians, and post-market complaint investigation lab technicians.
  • Lead the post-market regulatory compliance team to ensure compliant processing of global adverse events and execution of product field actions and assessments.
  • Primary contact for all escalated customer interactions related to product performance.
  • Identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated.
  • Serve as an internal resource to address and resolve any questions or issues of a regulatory nature; provide oversight to post-market RA team to ensure that regulatory decisions are sound and in support of the strategic goals
  • Leads team in the execution of Notified Body audits and Health Authority inspections.
  • Work is performed without appreciable direction and exercises significant latitude in determining technical objectives of assignments; assignments are often self-initiated; determines and pursue courses of action necessary to obtain desired results.
  • Responsible for Management oversight of Quality systems for functional area in compliance with 21 CFR Part 820, ISO 13485 and other applicable international regulations.
  • Responsible for integration of risk management into the quality system in compliance with ISO 14971
  • Oversees Quality Engineering teams to ensure existing products meet all quality specifications and establishment of policies and procedures to ensure ongoing compliance and quality in design.
  • Utilization of statistical analysis and trending (e.g.

    rejection rate/complaint rate monitoring) to implement process improvements

What You Need:

  • Bachelors degree in a scientific discipline, advanced degree preferred.
  • 10 to 15 years experience in a regulated industry required; medical device experience preferred.
  • 8+ years experience managing in a regulated industry required; medical device management experience preferred.
  • Industry certifications such as ISO 13485 lead auditor, CQE, CQM, or RAC preferred.
  • Demonstrated experience in preparing adverse event reports
  • Demonstrated experience in executing product field actions
  • Experience with global regulations, including experience with FDA, Health Canada, CE Marking and Japan MHLW/PMDA.
  • Thorough knowledge of FDA, QSR and ISO standards, regulations and requirements.
  • Direct management experience required/Exceptional leadership capabilities.

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.