Category: Scientific & Clinical
Job Title: Regulatory Project Manager Polaris Project
Contract Length: 6 mos
Number of Openings: 4
- Bachelor's degree required, Masters degree preferred
- Minimum of 6 years experience
- Demonstrated experience clearing devices in US Duties: Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
- Communicates issues to management through project management tracking and issue briefings.
- Position is highly visible to internal stakeholders.
- High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.
- Prior regulatory experience with IVDs or medical devices is required.
- Experience with CLIA waived products is a plus.
- Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.
- Ability to communicate effectively in writing crisp briefings and issue analysis.
- Demonstrated ability to work effectively in a team environment.
- Responsible for writing and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities. Responsible for effective communication of regulatory requirements to project teams and internal customers