Director of R&D, Innovation & Compliance

Stryker Group; Tempe (AZ); On-site; USD 156,000 - 260,000; Full time

Job summary

Stryker Sustainability Solutions seeks a Director of Research & Development to lead innovation, product development, and regulatory strategy for sustainable growth. This leader will guide R&D, Regulatory Affairs, Quality, and Program Management through development, compliance, and commercialization of new and expanded offerings.

The role emphasizes strategic leadership, cross-functional execution, and strong engagement with stakeholders to align product strategy with regulatory requirements and

Qualifications

• Bachelor’s degree in engineering or applicable technical field.
• 12+ years of experience in medical device, pharmaceuticals, biotechnology, or similarly regulated industry.
• 6+ years direct people management experience preferred.
• Master’s degree preferred.
• Working knowledge of FDA (GMP/QSR) and ISO requirements.
• 510K and premarket submission experience preferred.

Responsibilities

• Lead strategic and enterprise leadership within the Business Unit.
• Oversee product development and regulatory strategy from concept to commercialization.
• Ensure compliance with FDA, EU, and other regulatory requirements.
• Collaborate across R&D, Regulatory Affairs, Quality and Program Management.
• Drive cross-functional initiatives and portfolio performance.
• Own departmental budgets and financial performance.
• Build and develop a high-performing R&D organization.
• Develop future leaders and maintain a strong talent pipeline.

Skills

Cross-functional leadership

Negotiation

Communication

Business development

FDA GMP QSR knowledge

ISO requirements knowledge

Mentoring

Education

Bachelor’s degree in engineering or technical field

Master’s degree preferred

Job description

Stryker Sustainability Solutions seeks a Director of Research & Development to lead innovation, product development, and regulatory strategy for sustainable growth. This leader will guide R&D, Regulatory Affairs, Quality, and Program Management through development, compliance, and commercialization of new and expanded offerings.

The role emphasizes strategic leadership, cross-functional execution, and strong engagement with stakeholders to align product strategy with regulatory requirements and