Exactech
Exactech is a global medical technology company that empowers orthopaedic surgeons with innovative implants, surgical instruments and the Active Intelligence® (AI) ecosystem of smart technologies to give patients EXACTLY what they need to regain mobility$1. .$1
Orthopaedic • Medical Device • Orthopedic • Implant • Surgical Instrumentation
501 - 1000
Director of Regulatory Affairs, Lifecycle
July 22
🏡 Remote – New York
Exactech
Exactech is a global medical technology company that empowers orthopaedic surgeons with innovative implants, surgical instruments and the Active Intelligence® (AI) ecosystem of smart technologies to give patients EXACTLY what they need to regain mobility$1. .$1
Orthopaedic • Medical Device • Orthopedic • Implant • Surgical Instrumentation
501 - 1000
Description
• Provide strategic leadership for and oversight of the Lifecycle (Postmarket) Regulatory team • Responsible for hiring and terminations within the department as required • Ensure compliance to the code of ethics
Requirements
• Oversee the regulatory professionals who manage Exactech’s Lifecycle (postmarket) RA: • Practice leadership as stated in the Exactech Leadership Model • Communicate directly with regulatory agencies and health authorities regarding registrations, submissions and regulatory strategies • Develop and execute regulatory strategies and timelines to support proposed changes to commercialized product • Provide input to the change teams on project and test plans • Maintain awareness of the global regulatory environment • Collaborate with trade associations and regulators to help shape the regulatory environment • Oversee the regulatory review and approval of post-launch advertising and promotion • Oversee compliance with any regulatory Conditions of Approval • Support regulatory audits and inspections
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