Highridge Medical ยท 4 days ago
Regulatory / Quality Affairs -- Brazil
Westminster, CO
Full-time
Onsite
Senior Level
6+ years expHighridge Medical creates innovative spinal solutions and is seeking a Regulatory and Quality Affairs Manager to oversee quality assurance and regulatory compliance. This role will ensure alignment with Brazilian regulations while collaborating with cross-functional teams to maintain product quality and manage regulatory submissions.
ManufacturingMedical
Responsibilities
Ensure Compliance with Brazilian regulatory requirements per ANVISA standards for product registration, licensing, and post-market Surveillance
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
Monitor changes in Brazilian and Latin American regulations and advise on their impact to company operations
Liase with ANVISA and other regulatory bodies as the primary point of contact, and Technical Responsible person, in Brazil
Work with US based team members to develop global procedures that appropriately capture Brazilian requirements
Advise local and corporate leadership on regulatory and quality strategies for market expansion in Brazil and other Latin American markets
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
Conduct internal and external audits to ensure compliance with Quality Standards
Manage Non-Conformances (NCs) and Corrective Action/Preventive Actions (CAPAs) to resolve quality issues for the Brazilian site
Support global NCs and CAPAs to resolve quality issues which impact Brazil and Latin American markets
Ensure proper documentation and record keeping for quality and regulatory processes both within the Brazilian site and at any 3 rd party logistics providers in Brazil
Implement Vigilance systems to track product performance on the Brazilian Market
Organize and run Brazilian Management Review meetings
Provide training to local staff on regulatory requirements and quality standards
Host ANVISA for any audits that may need to take place at the Brazilian site
Qualification
Required
Fluent in Portuguese and English (written and verbal); Spanish is a plus
Ability to communicate effectively with cross-functional teams, international teams, company leadership, distributors, and regulatory authorities
Strong knowledge of Brazilian regulatory and quality requirements
Working knowledge of global regulatory and quality requirements
Ability to lead a team, influence others, and handle increasing levels of responsibility
Understands the overall business environment, the orthopedic industry, and the marketplace
Ability to identify and assess business risks to develop Regulatory strategy
Ability to manage/supervise employees and consultants
Excellent project management and problem-solving skills
Strong computer skills
Bachelor's Degree in a relevant field (e.g. life sciences, engineering, pharmacy, or related discipline)
6-8 years of experience required in a Regulatory and Quality Affairs capacity
Experience in the areas implantable medical device regulatory and quality affairs is strongly preferred
Preferred
Advanced degree preferred
Regulatory Affairs Certification (RAC) or Certified Quality Auditor (CQA) preferred
Company
Highridge Medical
Highridge Medical is a medical device company focused on designing and commercializing novel and proprietary products and solutions. It is a sub-organization of H.I.G. Capital.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2023-12-18Acquired
Recent News
2025-11-27
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