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Director, Research and Development

stryker · Tempe

New
Senior 155,900 - 259,700 USD/year 🇬🇧 English
ISO 510K Regulatory affairs Quality management system

Job description

About the role

Stryker is looking for a Director, Research and Development to lead its Sustainability Solutions (SSS) business unit. The role covers innovation, product development and regulatory strategy, overseeing the development and commercialization of new and expanded product offerings, ensuring compliance with global regulatory requirements and driving execution across R&D, Regulatory Affairs, Quality and Program Management. The position is onsite.

Key responsibilities

  • Lead the Business Unit Leadership Team, set functional and departmental strategy, and drive organizational alignment and decision-making.
  • Lead global R&D programs from concept through commercialization, manage project planning, resources, schedules and milestones, and foster innovation through Lean and problem-solving methods.
  • Ensure compliance with FDA, EU and other regulatory requirements, and provide leadership for design controls, product documentation and quality systems.
  • Review and approve technical and regulatory deliverables, and partner with key opinion leaders and external stakeholders on customer-focused innovation.
  • Collaborate across R&D, Quality, Regulatory, Operations, Marketing, Finance and Manufacturing, and lead complex cross-functional initiatives.
  • Own departmental budgets, resource planning and financial performance, and monitor portfolio performance through reporting and metrics.
  • Build and lead a diverse, high-performing R&D team, developing future leaders and maintaining a talent pipeline.

Required profile

  • Bachelor's degree in engineering or an applicable technical field; master's degree preferred.
  • 12+ years of experience in a medical device, pharmaceuticals, biotechnology or similarly regulated industry.
  • 6+ years of direct people management experience preferred.

Required skills

  • Knowledge of FDA (GMP/QSR) and ISO requirements.
  • Experience with 510K and premarket submissions preferred.
  • Ability to mentor in one or more technical disciplines and to communicate complex plans to executives.
  • Proven ability to deliver programs on time, to quality and within budget.

Pay range for the United States: $155,900 - $259,700 USD per year. No travel required.

Questions fréquentes

Le salaire proposé pour ce poste est de 156-260k USD par an. Le détail figure dans l'annonce.
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Source : ats:workday

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Published 19 hours ago

Expires 1 month from now

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stryker

Tempe