Quality Assurance Regulatory Affairs Manager...

Job Summary :

Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves.

The Regulatory and Quality Affairs Manager will oversee quality assurance and regulatory compliance for Highridge Medical’s operation in Brazil. This position will be responsible for ensuring local alignment with global regulations and standards and for ensuring corporate alignment with Brazilian regulations and standards. This role will collaborate with cross-functional teams locally and globally to maintain product quality, manage regulatory submissions, and support market access.

Regulatory Compliance :

• 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.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Quality Assurance :

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

Education / Experience Requirements :

Travel Requirements