- Candidate must have at least 3-5 years of QARA experience from Medical Devices company.
- Should have knowledge of regulation of Medical Devices for US FDA and Europe MDR
- Should be abreast with the upcoming regulatory changes into medical devices industry.
- Assist in the development of regulatory strategy and update strategy based upon regulatory changes
- Understand, investigate, and evaluate regulatory history/background of class, in order to assess regulatory implications
- Lead and executes EUMDR Transition projects (such as implementation of new / changed specific regulatory requirements) -
- Reviews Change Orders and assess regulatory impact of product changes per EUMDR and submissions per standard procedures
- Supports post market regulatory compliance activities
- Provides regulatory review of labeling, design changes, and specification changes
- Work with local RA teams, and develop International regulatory strategies for product submissions
- Work With cross functional team to lead & complete the technical file for EUMDR
- Work with offshore EUMDR Team.
- Ability to perform all assigned tasks, work independently, and complete work on schedule
- Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
- Strong problem-solving skills and efficient management of time and resources