Glutalor Medical Inc, based in Exton, PA , specializes development and manufacture of advanced continuous glucose monitoring products. It offers advantage of factory calibration, easy sensor placement and real-time readings/alerts. Its leading product iWel CG2 is currently being launched in European market.
- Develop and manage regulatory strategy for our medical device products
- Manage the regulatory affairs operation to support regulatory interactions and filings for our glucose monitoring products
- Draft and and review regulatory documents as necessary
- Interact with various government agencies for submission
- Ensure compliance to all applicable regulations
- Advanced training in life sciences or related field
- Minimum 7 plus years of experiences in FDA regulated medical device industry and a minimal of 3 years in management positions
- Proven track record in launch of new medical devices
- Extensive knowledge and experience in regulatory submissions with EU and FDA
- Excellent communication and personal skills
Flexible schedule and competitive benefits.
To apply, send your CV to firstname.lastname@example.org