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Job Description
What you will do
- Coordinates, compiles and submits U.S, and/ or International regulatory submissions, including filing and/or creation of IDEs, Premarket Notifications, PMA Supplements, Change Notifications, Technical Documents, Technical Files, Design Dossiers, and other country-specific product registrations.
- Manages the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products.
- Familiarity with clinical evaluation reporting (CERs), clinical data, and post-market data collection and summarization.
- Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
- Represents department on cross-functional product development and manufacturing support teams. Guide teams to provide content for US and/or International submissions, participates in design reviews as needed.
- Communicates with and maintains productive, constructive relationships with external customers as required – US FDA, Health Canada, in-country regulatory representatives, and notified-bodies.
- Participates in project development teams and reviews plans, reports, risk management and design reviews associated with product and process projects intended for inclusion in regulatory submissions.
- Assist in regulatory due diligence for potential and new acquisitions.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Job Requirements
Who you are
- Bachelor level degree required preferably in engineering, chemistry, physics, biology or related life science.
- 2-15 years related work experience.
- Minimum of 1 year of experience in the medical device industry required.
- Consulting experience preferred.
- Working knowledge of FDA Regulatory Regulations.
- EU MDR a plus.
