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Entry Level Regulatory Affairs Associate

Temecula, California, US
Closing date
Jan 15, 2022

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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We are seeking a Regulatory Affairs Associate for a Fortune 500 medical device company to join our team immediately.

Main Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Core job responsibilities for this function may include:

Provide regulatory input to product lifecycle planning.

Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.

Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.

Determine and communicate submission and approval requirements.

Participate in risk-benefit analysis for regulatory compliance Premarket

Monitor applications under regulatory review.

Evaluate proposed changes for regulatory filing strategies.

Assist in preparation and review of regulatory submission to authorities' Post-market

May help maintain annual licenses, registrations, and listings.

Assist compliance with product post-marketing approval requirements.

Assess external communications relative to regulations.

Assist with label development and review for compliance before release.

Submit and review change controls to determine the level of change and consequent submission requirements.

Maintain submission files (e.g. technical files)

Preferred Experience, Education, etc.:

Regulatory work experience or Internship from medical device industry

Will also consider experience from pharmaceutical industry.

Required Qualifications

Bachelor's Degree (or equivalent); Bachelor's Degree in science (biology,

chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.



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