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

Unspecified; São Paulo; Presencial; BRL 643.000 - 858.000; Tempo integral

Resumo da oferta

A global healthcare company is seeking a Regulatory Affairs Director for LATAM in São Paulo, Brazil. This role involves overseeing the Regulatory Affairs team to ensure compliance and secure licenses for medical devices. The ideal candidate has over 10 years of experience in Regulatory Affairs, strong management skills, and fluency in English and Portuguese. Excellent communication and influencing skills are essential. Competitive salary offered for this key position.

Qualificações

• Minimum of 10 years of experience in Regulatory Affairs of medical devices.
• At least 5 years in a supervisory/managerial level with proven success.
• In-depth knowledge of Medical Device regulations in Latin America.

Responsabilidades

• Define regulatory strategies and ensure timely execution.
• Build relationships with Health Authorities to shape regulations.
• Hire and train the Regulatory Affairs team.

Conhecimentos

Fluent English

Fluent Portuguese

Intermediate/advanced Spanish

Strong influencing skills

Excellent communication skills

Formação académica

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

Descrição da oferta de emprego

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

BRL 643.000 - 858.000

At Abbott, we're 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.

Abbott is currently looking to recruit a

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

This position is responsible for the development and direction of the Regulatory Affairs team in Latin America to obtain necessary approvals and licenses to increase and maintain the portfolio of following Medical Device divisions: CRM / EP / HF / SH / NM / VAS.

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 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.
• 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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.