Director of Regulatory Affairs - Lifecycle

September 25

Apply Now

Receive Emails with Similar Jobs

Exactech

WebsiteLinkedInAll Job Openings

Orthopaedic • Medical Device • Orthopedic • Implant • Surgical Instrumentation

501 - 1000

Description

• The Director, Lifecycle RA provides strategic leadership and oversight of the Lifecycle Regulatory team • Accountabilities include assessment of proposed changes for regulatory impact and regulatory strategy • Partner with business and regulatory colleagues to develop global regulatory strategies • Oversee the regulatory professionals who manage Exactech’s Lifecycle Regulatory Affairs • Ensure organizational alignment in initiative efforts and establish defined individual goals • Communicate with regulatory agencies and health authorities regarding registrations and submissions • Develop and execute regulatory strategies and timelines to support proposed changes • Maintain awareness of the global regulatory environment and assess environmental changes • Oversee the regulatory review and approval of post-launch advertising and promotion • Support regulatory audits and inspections and interpret medical device regulations and standards

Requirements

• A minimum of a Bachelor’s Degree from an accredited institution, preferably in physical or life sciences; Master’s Degree preferred • Minimum 10 years’ experience in medical device industry in regulatory affairs or related field, orthopaedic device industry experience preferred. • Experience in US, EU and/or international submissions/registrations required • Working knowledge of US, EU and international medical device regulations required • Demonstrated experience leading in-depth technical and strategic discussions with Health Authorities required • Demonstrated ability to influence and negotiate with cross-functional partners and stakeholders, both internal and external required • Prior team leadership required • Regulatory Affairs Certification (RAC) preferred • Proficiency with windows-based office productivity tools (Microsoft Office)