Regulatory Affairs Specialist

Medline Industries; Brasil; Teletrabalho; BRL 479.000 - 615.000; Tempo integral

Resumo da oferta

A leading medical company is seeking a professional with experience in regulatory affairs to manage compliance in Brazil. Responsibilities include planning regulatory activities, communicating requirements, and collaborating on filings. An ideal candidate holds a relevant degree, has 2 years of experience in the field, and possesses a thorough understanding of FDA regulations. The position offers competitive compensation and comprehensive benefits.

Serviços

Comprehensive benefits package

Opportunities for continuing education

Supportive work environment

Qualificações

• Minimum of 2 years of experience in medical device regulatory affairs or quality assurance.
• Understanding of the current regulatory environment.
• Applied knowledge of FDA regulations and guidelines.

Responsabilidades

• Plan and execute global regulatory activities for obtaining approvals.
• Communicate regulatory requirements to internal and external customers.
• Collaborate on maintaining regulatory filings.

Conhecimentos

Regulatory affairs

Quality assurance

Problem-solving

Formação académica

B.A. or B.S. degree in a life science field, engineering, medical technology, regulatory science

Descrição da oferta de emprego

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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