Regulatory Affair

3 weeks ago

Santa Clara, United States Select Source International Full time
Job DescriptionJob Description

Title: - Regulatory Affairs Project Leader
Duration: - 12+ Month


Education: Bachelor's degree required, Master’s degree preferred Experience: 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.
Must have RA submission experience. and EU & MU submissions experience

Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.

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