Description

• 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