
Senior Regulatory Specialist
Há 3 dias
The Role:
We are seeking a highly skilled Regulatory Affairs Specialist to lead our regulatory strategy in Brazil.
The ideal candidate will be responsible for ensuring compliance with Brazilian regulatory requirements, preparing and submitting regulatory dossiers, and managing market access.
Main Responsibilities:
- Ensure Compliance with Brazilian regulatory requirements per ANVISA standards.
- Prepare, submit, and manage regulatory dossiers for product approvals, renewals, and significant changes in Brazil.
- Act as primary point of contact for Latin American distributors who are building dossiers to submit for approvals, renewals, and significant changes in their markets.
Quality Management:
- Maintain and improve the local Quality Management System in accordance with Brazilian GMP and international standards.
- Partner with corporate quality and regulatory teams to ensure global alignment of policies and procedures.
Requirements:
- Fluent in Portuguese and English (written and verbal); Spanish is a plus.
- Ability to communicate effectively with cross-functional teams, international teams, and regulatory authorities.
Preferred Qualifications:
- Regulatory Affairs Certification (RAC) or Certified Quality Auditor (CQA).
- Experience in the areas implantable medical device regulatory and quality affairs.
To Succeed in This Role:
You will need to possess strong analytical and problem-solving skills, excellent communication and interpersonal skills, and the ability to work effectively in a fast-paced environment.
We offer a competitive compensation package and opportunities for professional growth and development.
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