Regulatory Affairs Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil Align Technology Tempo inteiro

Department:
Quality

Location:
LATAM-Brazil-Sao Paulo

Description
Role summary
This position is ideal for mid- to senior-level Regulatory Affairs professionals to join the LATAM RAQA Team as a Regulatory Affairs Specialist, ensuring regulatory compliance with local regulations and applicable standards. Partnering with cross-functional teams, you will provide a regulatory strategy to enable product sales. This role is critical to maintaining Align's regulatory compliance and supporting product commercialization in Brazil, with a direct impact on business success.

In this role, you will…

  • Support market clearance for new products and changes to existing products (approval, renewal, and amendment of product licenses).
  • Manage certification processes with regulatory bodies such as ANVISA, INMETRO, and ANATEL.
  • Ensure compliance with local labeling requirements applicable to medical devices in Brazil, collaborating with manufacturing teams during implementation.
  • Interact directly with distributors, regulatory consultants, and health authorities.
  • Collaborate with the Supply Chain, Marketing, and Commercial teams to support product launches and approve marketing materials.
  • Responsible for post-market obligations, including adverse event reporting and Field Safety Corrective Action (FSCA) notifications, ensuring proper documentation and timely resolution.
  • Support cross-functional teams in performing impact assessments of product or manufacturing changes.
  • Monitor local regulations and identify potential impacts on the company that could affect regulatory compliance.

In this role, you'll need…

  • Education: University degree in Pharmacy, Chemistry, Biomedical Engineering, Dentistry, or similar.
  • Expertise in product registration; knowledge of INMETRO, ANATEL, and GMP certifications - preferably experience with LATAM regulations.
  • 5+ years of experience in regulatory affairs for medical devices.
  • Ability to work cross-functionally on multiple projects, solve problems, and communicate effectively.
  • Capable of executing project/program tasks with general supervision and minimal guidance.
  • Advanced English and intermediate to advanced Spanish preferred.
  • Ability to work both independently and collaboratively.
  • Strong organizational and top presentation skills.

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Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.

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