Entry Level Regulatory Affairs Associate
- Employer
- Medix
- Location
- Temecula, California, US
- Salary
- Competitive
- Closing date
- Jan 15, 2022
View more
- Sector
- Consultancy/Private Sector
- Field
- Conservation science
- Discipline
- Other
- Salary Type
- Salary
- 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.
Compensation:
22/hr
Apply Today!
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.
Compensation:
22/hr
Apply Today!
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