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Latam Regulatory Affairs Leader Medtech

hace 4 semanas

Bogota, Colombia Johnson & Johnson A tiempo completo

Johnson & Johnson MedTech is one of three successful divisions of the world's leading Johnson & Johnson family of companies. We are making an important contribution to the successful treatment of a wide range of common and chronic diseases with innovative - often pioneering - medical technologies and products.

Are you ready to take your regulatory affairs career to the next level? Johnson & Johnson, a globally renowned family of companies committed to transforming healthcare, is currently recruiting for a Regulatory Affairs Leader - LATAM for our MedTech division. In this exciting role, you will have leadership responsibilities for Argentina, Brazil, Colombia, Peru, Ecuador, Panama, Costa Rica, and Mexico.

**Key Responsibilities**:
As the Regulatory Affairs Senior Director for Latin America, you will play a pivotal role in driving regulatory excellence across multiple countries. Your responsibilities include:

- **Strategic Leadership**: Lead our regional Regulatory Affairs teams in Argentina, Brazil, Colombia, Peru, Ecuador, Panama, Costa Rica, and Mexico. Develop and execute regulatory strategies to support and enhance business growth within the MedTech division.
- **Visionary Strategy**: Define a clear and influential future vision and strategy for regulatory affairs in the LATAM region. Align your strategies with global regulatory requirements and regional business objectives.
- **Technological Advancement**: Drive the adoption and utilization of cutting-edge technologies to optimize data-driven decision-making and enhance transparency in enterprise systems across Latin America.
- **Strategic Planning**: Establish short-term and long-term strategic goals, implementation plans, and provide guidance on regional, country, and cultural differences that may impact our business.
- **Regulatory Engagement**: Proactively shape the external regulatory environment and engage with regulators across Latin America to influence regulatory harmonization.
- **Product Approvals**: Accelerate product approvals by developing and executing regulatory strategies aligned with business objectives. Ensure product compliance with regulatory requirements and stay vigilant to regulatory changes.
- **Budget Management**:Take responsibility for detailed Regulatory Affairs budget planning and control. Manage projects and regulatory activities within timelines and budget requirements, while communicating the financial implications of regulatory activities on business results.
- **Acquisitions and Divestitures**: Support key acquisitions and divestitures by providing comprehensive regulatory assessments and the necessary expertise and resources.
- **Collaborative Partnerships**: Establish close and collaborative partnerships with business and functional stakeholders in the Latin American region, defining interdependencies and priorities.
- **Cross-Functional Projects**: Collaborate with Quality and Supply Chain teams on related projects to drive change management, labeling, cost improvement, and transformation projects, while providing timely regulatory assessments.
- **Talent Development**:Build a diverse and capable regulatory workforce, emphasizing the importance of recognizing and embracing cultural differences. Create a sustainable talent pipeline through recruitment, retention, and development strategies.
- **Regulatory Excellence**: Support the development of a regulatory sustainable model, focusing on process excellence, effective tools, systems, and efficiency improvements.
- **Global and Regional Leadership**: Act as an active member of the global regulatory affairs leadership team, advising on global strategy, regional impact, and priorities. Collaborate with business sector regulatory affairs and functional leaders to execute the global regulatory affairs strategy.

This is a unique opportunity to lead regulatory affairs efforts across multiple countries in Latin America, making a significant impact on the healthcare industry in the region. If you are a dynamic and forward-thinking regulatory affairs professional with a passion for leadership and a desire to shape the future of healthcare through innovation and excellence, we invite you to join our team at Johnson & Johnson.

**Qualifications**:

- A Bachelor's degree or higher is a must. We highly value advanced degrees and education in fields such as medicine, engineering, science, or law.
- You should bring a wealth of experience in a regulated industry, especially in management positions where you've successfully led teams.
- Medical device experience is preferred. Global franchise / business unit RA experience supporting an OUS market with diversity of experience - i.e. sector, company, function, product.
- Regulatory compliance risk evaluation and balanced decision making
- Experience leading diverse teams in a matrix environment, cultural awareness, Talent Management in competitive markets
- Large budget cost center management and business planning in a complex fi