Develops and implements regulatory strategies for new and modified products
Acts as a core member on new product development and sustaining teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions
Prepares and submits regulatory applications, as well as internal regulatory file documentation
Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Provides guidance to other team members during strategy formulation, submission preparation and interaction with regulatory bodies
Supports international regulatory partners with commercial marketing applications
Supports efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
Supports external audits and maintain audit readiness
Qualifications
Minimum of a Bachelor's Degree in a scientific or technical discipline
Minimum of 7 years of experience in the medical device industry, or 5 years’ experience with an advanced degree (Master’s or PhD)
Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards
Demonstrated experience authoring/supporting a variety of regulatory submissions
Demonstrated ability to effectively lead multiple regulatory projects and priorities
Excellent written and oral communication, technical writing, and editing skills
Ability to articulate complex ideas clearly both verbally and in writing
Ability to work independently with minimal supervision, as well as mentor/guide others
