Especialista em Assuntos Regulatórios

Additional Locations: N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Responsibilities:

• Develop local strategies for regulatory approval in collaboration with Marketing, Planning, and International Division teams.
• Coordinate, compile, and submit regulatory filings for new and modified products to ANVISA, INMETRO, and ANATEL.
• Review product and manufacturing changes for compliance with applicable regulations and assess the impact on regulatory filings.
• Coordinate the localization process to ensure compliance with Brazil's labeling requirements.
• Review promotional materials.

• Represent Regulatory Affairs on cross-functional projects, providing regulatory feedback and guidance, including involvement in process changes, continuous improvement efforts, and acceleration towards digital transformation.
• Foster positive relationships with regulatory agencies and industry associations through verbal and written communications, acting as the focal point for regulatory advocacy in Brazil.

Required Qualifications:

• Solid experience in the medical device Regulatory Affairs field.
• Knowledge of ANVISA regulations; desirable familiarity with INMETRO and ANATEL regulation.
• Bachelor's Degree in Pharmacy, Biochemistry, Health Technology, Biomedical Engineering, or related fields.
• Advanced proficiency in English.
• Experience in interactions with regulators: Regulatory Intelligence, Advocacy, and/or Policy.
• Ability to read, analyze, and interpret general, scientific, and business periodicals, as well as governmental regulations.
• Excellent attention to detail with the ability to identify trends and gaps.
• Ability to manage databases in software and systems.
• Effective communication of complex ideas, both verbally and in writing, good drafting skills.
• Team player with excellent interpersonal skills and strong problem-solving skills.

Preferred Qualifications:

• General knowledge of global or LATAM regulations is an asset.
• Intermediate proficiency in Spanish is desirable.

Requisition ID: 576696

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!