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Regulatory Affair Specialist

3 months ago

Santa Clara, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

Position: Regulatory Affair Specialist

Location: Santa Clara, CA

Duration: 1+ year of contract


Responsibilities:

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

Qualification: Bachelor's degree in engineering or science and a minimum of 3 years of experience of regulatory affairs.

Required Skills:

  • Must have RA submission experience. and EU & US submissions experience
  • 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
  • good writing and communication skills - Word, Excel