Regulatory Affairs Director LATAM – Medical Devices (mfd)

Abbott; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading healthcare company is looking for a Regulatory Affairs Director for LATAM Medical Devices in São Paulo. This role requires at least 10 years of regulatory affairs experience with medical devices and strong supervisory skills. You will define regulatory strategies, manage a team, and ensure compliance for product launches. The ideal candidate will be fluent in English and Portuguese, with solid knowledge of Latin American medical device regulations. Join us to make a significant impact on healthcare in the region.

Qualificações

• Fluent in English and Portuguese; intermediate/advanced level in Spanish.
• Minimum of 10 years of experience in Regulatory Affairs of medical devices.
• At least 5 years in a supervisory/managerial role with success in a matrixed environment.

Responsabilidades

• Define regulatory strategies and align resources.
• Provide regulatory solutions for different business models.
• Hire and support the Regulatory Affairs team.
• Build relationships with Health Authorities.
• Ensure compliance for product launches.
• Manage regional budget and resources.

Conhecimentos

Proofreading

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Writing Skills

Formação académica

Bachelor’s Degree in Biomedical Science, Pharmacy, Biomedical Engineering or related field

Descrição da oferta de emprego

Job Description

At Abbott we are committed to helping people live their best possible life through the power of health. For more than 125 years we’ve brought new products and technologies to the world in nutrition, diagnostics, medical devices and branded generic pharmaceuticals that create more possibilities for more people at all stages of life. Today 114,000 of us are working to help people live not just longer but better in the more than 160 countries we serve.

Position

Regulatory Affairs Director LATAM Medical Devices (m / f / d)

Location

Based in São Paulo Brazil

Rua Itapeva 538-5 ao 8 andares B

Main Responsibilities

• Define regulatory strategies and align resources to execute essential regulatory tasks in a timely manner ensuring no business disruption in the region.
• Provide the best regulatory solutions for each business model in the region covering both direct subsidiaries and multi-distributor networks.
• Hire, train and support the Regulatory Affairs team and determine the optimal organizational structure to meet group objectives.
• Build strong relationships with Health Authorities and other external stakeholders. Act proactively with these Health Authorities in the region to shape and implement emerging regulations without business disruption. Monitor these new regulations, analyze their impact, determine implementation strategies and ensure proper documentation in company systems.
• Maintain close collaboration with Marketing Operations and Sales teams to ensure compliant product launches according to local regulations.
• Align team responsibilities and activities with the demands of business units and senior Regulatory Affairs leadership.
• Ensure that Regulatory Projects in the region are properly managed and resourced to promote continuous improvement of regulatory processes.
• Identify opportunities, anticipate risks and enable effective contingency plans when necessary to achieve goals and accelerate opportunities.
• Continuously monitor the competitive landscape and provide valuable regulatory insights for business planning.
• Build personal credibility and strong working relationships capable of engaging and / or leading high-performance cross‑functional teams.
• Manage regional budget and resources.
• Ensure compliance with activity metrics under your responsibility as well as internal / external customer satisfaction and implement corrective or preventive actions when necessary.
• Conduct actions and decisions under your responsibility in accordance with the company’s Code of Business Conduct.
• Support EHS (Environment Health and Safety) policies and practices by participating in and promoting area initiatives.

Education

Bachelor’s Degree in Biomedical Science, Pharmacy, Biomedical Engineering or a related field.

Fluent in English & Portuguese; intermediate / advanced level in Spanish.

Experience

• Minimum of 10 years of experience in Regulatory Affairs of medical devices.
• At least 5 years of experience in a supervisory / managerial level with proven success in a highly matrixed environment.
• Track record in working with trade associations in the region.

Competencies

• Ability to build partnerships and collaborate across organizations, regions and with external partners to achieve results.
• Strong influencing skills with stakeholders across different areas / functions.
• In‑depth knowledge of Medical Device regulations in Latin America.
• Excellent verbal and written communication skills.
• Strong negotiation and persuasion abilities.

Key Skills

Proofreading, Adobe Acrobat, FDA Regulations, Manufacturing & Controls, Biotechnology, Clinical Trials, Research & Development, GLP, cGMP, Product Development, Chemistry, Writing Skills

Employment

Full‑Time, Director level, 1 vacancy.

Other Information

Standard work shift.

Travel: Not specified.

Medical Surveillance: Not applicable.

Significant work activities: Not applicable.

EEO Statement

Abbott is an Equal Opportunity Employer committed to employee diversity.