Regulatory Affairs Specialist

3 weeks ago


Santa Clara, United States CareerBuilder Full time

Regulatory Affairs Project Lead 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:
Bachelors 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

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