Regulatory Affairs Specialist
2 weeks ago
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:
- 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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