Position Overview::
This position authors regulatory submissions and technical documentation to support OUS markets as well as organizes regulatory information and tracks/controls submissions. Reviews and provides recommendations on labeling for compliance with regulatory filings. Performs reviews of product changes for impact on regulatory filings worldwide.
What you will do::
- Provide regulatory guidance to colleagues to ensure subsequent documentation will meet the needs of the regulatory submissions.
- Prepare European technical documentation and other OUS license applications.
- Lead project for gap remediation with a cross functional team.
- Prepares and submits filings.
- Maintain regulatory files/database and chronologies in good order.
- Establish and maintain system for tracking changes in documents submitted to agencies or partners.
- Review labeling and labels for compliance with regulatory requirements.
- Review changes to existing products and SOPs to define the requirements for regulatory submissions.
Skills for Success::
- Bachelor's degree in science, math or engineering discipline required.
- 5+ years relevant experience in FDA regulated industry.
- Experience and knowledge within medical device industry (disposable devices preferred).
- Knowledge of international regulatory requirements applicable to medical devices.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Strong attention to detail and ability to manage multiple projects simultaneously.