Regulatory Affairs Project Leader

Title: Regulatory Affairs Project Leader

Location: Santa Clara, CA

Duration: 12+ Months

Qualifications:

• Must have RA submission experience. and EU & MU submissions experience
• good writing and communication skills - Word, Excel
• Bachelor's degree in engineering or science and a minimum of 3 years of experience of regulatory affairs

Day to day:

• Registrations - will train to do this
• up to 200 pages of documentation formatting
• complete technical documents for different Countries and submit to government agencies as well as the US.

 Exempt/Non-Exempt:

• Minimum of 3 years of Regulatory Affairs experience Skills.
• Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or device submissions.
• Hands-on experience with 510k submission, or PMA/s or US Annual report or CE Technical Documentation preparation.
• 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 material activities. Responsible for effective communication of regulatory requirements to project teams and internal customers.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.