Principal Regulatory Specialist
December 21
Description
•The Principal Regulatory Specialist provides regulatory support of commercialized products. •Accountabilities include activities such as assessment of proposed changes for regulatory impact, regulatory strategy and support for change projects, compliance with Conditions of Approval, EU renewals and regulatory review & approval of advertising and promotion. •The Regulatory Specialist will partner with the cross functional team members and regulatory colleagues to develop and execute global regulatory strategies in support of commercialized products.
Requirements
•Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred •Minimum of 10 years’ experience in the medical device industry specifically in Regulatory Affairs. •Bachelor’s Degree in physical or life sciences preferred. •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 •Regulatory Affairs Certification (RAC) preferred •Proficiency with windows-based office productivity tools (Microsoft Office)
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