Regulatory Affairs Specialist Santa Clara, CA

Must be able to work on a W2

Job Summary : We are seeking a regulatory affairs specialist to assist and lead in the definition / implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.

Key Responsibilities :

Duties :

• Assist in the definition / implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel
• Communicate issues to management through project management tracking and issue briefings
• Maintain high visibility to internal and external stakeholders
• Demonstrate a high level of effective verbal and written communication skills, including negotiation, influencing, and conflict management
• Work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs
• Manage and track broad and strategic projects
• Communicate effectively in writing crisp briefings and issue analysis
• Work effectively in a team environment
• Track and ensure timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label / promotional material activities
• Communicate regulatory requirements to project teams and internal customers effectively

Qualifications :

• Bachelor’s degree required in engineering or science, masters preferred
• Minimum of 3 years of experience in regulatory affairs
• Knowledge of US and / or Canadian regulations relating to product and / or device clearance (FDA) or with EU and other international medical device regulation submissions
• Hands-on experience with 510k submissions, or PMA / s or US Annual report or CE Technical documentation preparation
• Ability to negotiate, influence, and manage conflict
• Prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry preferred, but not required
• Ability to work constructively, decisively, and collegially with internal customers
• Ability to manage and track broad and strategic projects
• Demonstrated ability to write crisp briefings and issue analysis

Term & Start

• 12-month contract with possibility to extend
• FT, M-F 40hr / week
• Pay Rate : $49-54 / HR (98-108K Annually)
• Onsite in Santa Clara, CA
2 days ago