Regulatory Affairs Senior Specialist

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:

• 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 3rd 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.

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

• 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. Direct experience with spinal implant companies is a plus.
• 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.

Education/Experience Requirements:

• Bachelor's Degree in a relevant field (e.g. life sciences, engineering, pharmacy, or related discipline).
• Advanced degree preferred
• 6-8 years of experience required in a Regulatory and Quality Affairs capacity.
• Regulatory Affairs Certification (RAC) or Certified Quality Auditor (CQA) preferred
• Experience in the areas implantable medical device regulatory and quality affairs is strongly preferred.
• A combination of education and experience may be considered

Travel Requirements

• Up to 15%