Regulatory Affairs Project Leader

4 days ago

Santa Clara, United States Rangam Consultants Full time

Regulatory Affairs Project Leader in Santa Clara, CA

Title:

Regulatory Affairs Project Leader 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

Knowledge of US and/or Canadian, EU regulation relating to product and/or device clearance (FDA)

Creation and/or maintenance of EU MDR Technical Documentation

Prepare and submit product for international registration

In addition to the key words, forgot to mention: PMA, IDE submission 510(k) submission 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. Education : 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. Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries. Rangam strives to put job seekers first, giving them free access to search for jobs, post resumes, and research companies.Every day, we connect millions of people to new opportunities. Welcome I'm here to help. Ask me anything about our products or services. Let's get started

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