What are the responsibilities and job description for the Regulatory Affairs Project Leader position at DGN Technologies?
Job title: Regulatory Affairs Project Leader
Job location: Santa Clara, CA 95054 (Onsite Role)
Contract Position
Job Description:
Education:
Bachelor's degree required; Master’s degree preferred
Experience: Minimum of 3 years’ experience
Skills:
- Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)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 and external stakeholders.
- High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.
- Prior regulatory experience in the medical device, food, dietary supplement or pharmaceutical industry is strongly preferred, but not required.
- 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 manage and track broad and strategic projects.
- Ability to communicate effectively in writing crisp briefings and issue analysis. Demonstrated ability to work effectively in a team environment.
- Responsible for tracking 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.
- Equivalent to Grade 18 at Abbott
Job Types: Full-time, Contract
Pay: $50.00 - $60.00 per hour
Benefits:
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
Work Location: In person
Salary : $50 - $60
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