Regulatory Affairs Specialist

Há 2 dias

Uberlândia, Brasil Medline Industries Tempo inteiro

Overview

Why consider this job opportunity:

  • Salary up to $115,440.00 annually
  • Bonus and/or incentive eligible
  • Comprehensive benefits package including health insurance, 401(k) contributions, and paid time off
  • Opportunities for continuing education and training within a growing global organization
  • Supportive and inclusive work environment that promotes diversity and career growth
  • Potential for travel up to 5%
Responsibilities
  • Plan and execute global regulatory activities necessary for obtaining and maintaining regulatory approvals
  • Determine requirements for product submissions and regulatory filings in assigned markets
  • Communicate regulatory requirements to internal and external customers and recommend strategies
  • Collaborate with teams to complete and maintain regulatory filings, addressing non-conformances and questions from regulators
  • Participate in the development and review of product labeling and claims
Qualifications
  • B.A. or B.S. degree in a life science field, engineering, medical technology, regulatory science, or related area
  • Minimum of 2 years of experience in medical device regulatory affairs or quality assurance
  • Understanding of the current regulatory environment and ability to perform within it
  • Applied knowledge of FDA regulations and guidelines
  • Ability to evaluate information for compliance with standards, laws, and regulations
Preferred Qualifications
  • Experience with product submissions and regulatory strategies in a global context
  • Familiarity with medical device labeling requirements and claims substantiation
  • Strong problem-solving skills and ability to act as a regulatory subject matter expert

#MedicalDevices #RegulatoryAffairs #CareerGrowth #CompetitiveCompensation #DiversityAndInclusion

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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.

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