Global Regulatory Affairs Leader – Medical Devices

Stryker Corporation; Portage (MI); Hybrid; Vertraulich; Vollzeit

Benefits dieser Stelle

Equal opportunity employer

Zusammenfassung

Stryker Corporation is seeking a Manager, Regulatory Affairs in Portage, Michigan. The role is hybrid with onsite collaboration at least three days per week and involves guiding global regulatory strategy across the product lifecycle.

You will lead regulatory processes, interact with authorities, and develop talent while partnering with R&D, Quality, Manufacturing, and Commercial teams to ensure compliant, timely product development and market access.

Qualifikationen

• Bachelor’s degree in a scientific/engineering discipline.
• Minimum 6 years in medical device/pharma industry.
• Experience with regulatory submissions and authority interactions.
• People management experience.

Aufgaben

• Lead and develop a high-performing regulatory team with clear priorities and development plans.
• Translate evolving regulatory requirements into actionable market access plans.
• Provide strategic regulatory guidance to R&D, Quality, Clinical, Manufacturing and Commercial teams.
• Oversee regulatory submissions, registrations, agency interactions, inspections and audits.
• Lead regulatory negotiations with global authorities and external stakeholders.
• Oversee regulatory processes, issue evaluation and escalation.

Ausbildung

Bachelor's degree in Engineering/Life Sciences/ Regulatory Affairs

Master’s degree in Engineering/Life Sciences/ Regulatory Affairs

Jobbeschreibung

Stryker Corporation is seeking a Manager, Regulatory Affairs in Portage, Michigan. The role is hybrid with onsite collaboration at least three days per week and involves guiding global regulatory strategy across the product lifecycle.

You will lead regulatory processes, interact with authorities, and develop talent while partnering with R&D, Quality, Manufacturing, and Commercial teams to ensure compliant, timely product development and market access.