Senior Regulatory and Quality Assurance Specialist

This role oversees quality assurance and regulatory compliance for operations in Brazil.

The ideal candidate will ensure local alignment with global regulations and standards, as well as corporate alignment with Brazilian regulations and standards.

Responsibilities include:

• Ensuring Compliance with Brazilian regulatory requirements per ANVISA standards for product registration, licensing, and post-market Surveillance.
• Preparing, submitting, and managing regulatory dossiers for product approvals, renewals, and significant changes in Brazil.
• Acting as primary point of contact for Latin American distributors who are building dossiers to submit for approvals, renewals, and significant changes in their markets.
• Monitoring changes in Brazilian and Latin American regulations and advising on their impact to company operations.
• Liasing with ANVISA and other regulatory bodies as the primary point of contact, and Technical Responsible person, in Brazil.
• Working with US based team members to develop global procedures that appropriately capture Brazilian requirements.
• Advising 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.

Additionally, this role will:

• Maintaining and improving the local Quality Management System in accordance with Brazilian GMP and international standards.
• Partnering with corporate quality and regulatory teams to ensure global alignment of policies and procedures.
• Conducting internal and external audits to ensure compliance with Quality Standards.
• Managing Non-Conformances (NCs) and Corrective Action/Preventative Actions (CAPAs) to resolve quality issues for the Brazilian site.
• Supporting global NCs and CAPAs to resolve quality issues which impact Brazil and Latin American markets.
• Ensuring proper documentation and record keeping for quality and regulatory processes both within the Brazilian site and at any 3rd party logistics providers in Brazil.
• Implementing Vigilance systems to track product performance on the Brazilian Market.
• Organizing and running Brazilian Management Review meetings.
• Providing training to local staff on regulatory requirements and quality standards.
• Hosting ANVISA for any audits that may need to take place at the Brazilian site.

Requirements:

• 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.
• Understanding 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%.