Associate Regulatory Affairs Specialist

hace 2 semanas

Lima, Perú Medtronic A tiempo completo

**Careers that Change Lives
**In this exciting role as an Associate Regulatory Affairs Specialist, you will be in charge to prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned by Senior Supervisor or RA Manager. While being the focal point for Operating Units (OU) and countries under your scope about regulatory processes for all stakeholders.

You will help identify the requirements for local Ministry of Health (MoH) and provide guidance to centre-led team to plan timelines and registration strategies, including initial submissions, amendments, changes, and any other regulatory activities for Latin America (LATAM), following the instructions of the RA Manager and/or Senior RA Specialist.

**A Day in the Life
Responsibilities may include the following and other duties may be assigned:

- Ability to communicate clearly in writing and verbally with RA teams, Operating Unit (OU, other areas, etc.
- Review submission dossiers, renewals, and respond to government queries. Work with the RA Manager or Senior Supervisor to provide answers to those questions.
- Follow up with Business, Marketing, cross-functions, and Centre-led team Units to ensure submission planning.
- Collaborate with centre-led regulatory team on new product and changes that require submission and prior approval. Notify business partners, international, regional, and local teams of approvals.
- Verify and validate the information to be published in the databases.
- Attend any training related to local regulation provided by RA Local teams, consultants, etc.
- Provide the necessary information to create statistical reports and support budget preparation for LATAM countries.
- Keep up with changes in regulatory legislation and guidelines as an expert in the regulation.
- Maintain updated the Medtronic tool (Excel, Smartsheet) designated to track the progress of the regulatory processes.
- Participate in frequently strategic reviews with Internationals OUs, Business Partners, and RA Local Teams.

**Must Have: Minimum Requirements
- BA/BS degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience
- Advance proficiency in both Spanish and English required (reading, writing, and speaking)
- Minimum 1 year of relevant in the Regulatory Affairs field
- High proficiency in Microsoft tools
- Databases management
- Ability to work in matrix structured organization
- Document interpretation, queries, and workflow skills
- Excellent communication and presentation skills
- Analytical and problem-solving skills; Strategic thinking and decision-making skills
- Strong organization and time management skills Ability to work as a team

**Nice to Have
Desirable regulatory affairs experience in medical devices or pharmaceutical industry

**About Medtronic
**Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

  • Regulatory Affairs Jr Analyst

    hace 1 mes

    Lima, Perú Johnson & Johnson A tiempo completo

    En Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad. La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y...

  • Senior Director, Corporate Affairs, Latam Area

    hace 4 semanas

    Lima, Perú AstraZeneca A tiempo completo

    **Senior Director, Corporate Affairs, LatAm Area*** Location: LatAm (all regions considered) Competitive salary and benefits package The Senior Director, Corporate Affairs, LatAm will lead the development and delivery of an integrated corporate affairs plan to drive key regional business objectives and enhance global, regional, and local alignment. As...

  • Senior Associate, Public Finance

    hace 4 semanas

    Lima, Perú Global Green Growth Institute A tiempo completo

    The Senior Associate, Public Finance will support GGGI's Peru Country Program in the framework of the Norway-financed project for the implementation of Agroforestry Concessions (AC). Specifically, the Senior Associate, Public Finance will help the national government of Peru and three regional governments, San Martín, Amazonas, and Loreto, analyze and...

  • Senior Associate, Infrastructure Specialist

    hace 4 semanas

    Lima, Perú Kyndryl Peru SRL A tiempo completo

    **Why Kyndryl** Kyndryl is a market leader that thinks and acts like a start-up. We design, build, manage, and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward - always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our...

  • Government Affairs Professional for South America

    hace 3 días

    Lima, Perú Siemens Energy A tiempo completo

    **A Snapshot of Your Day** As Government Affairs you will be working for maintaining and enhancing positive relations with external audiences, including the public, shareholders, associations, entity class, investors, government, and communities in the countries of the Subregion South America (Peru, Chile, Paraguay, Argentina, Bolivia) The role will be...

  • Especialista de Asuntos Regulatorios Senior

    hace 4 semanas

    Lima, Perú Abbott Laboratories A tiempo completo

    **Acerca de Abbott** Abbott es líder mundial en cuidado de la salud, que crea ciencia innovadora para mejorar la salud de las personas. Siempre estamos mirando hacia el futuro, anticipando cambios en la ciencia y la tecnología médica. **Trabajando en Abbott** En Abbott, puedes hacer un trabajo que importa, crecer y aprender, cuidar de sí mismo y de tu...

  • Country Approval Associate

    hace 4 semanas

    Lima, Perú Thermo Fisher Scientific A tiempo completo

    Prepares, reviews, and coordinates local EC submissions in alignment with the global submission strategy. Supports the preparation of local MoH submissions as applicable, in alignment with the global submission strategy. May coordinate with internal functional departments to ensure various site start-up activities are aligned with submission activities and...

  • Manager Compliance

    hace 4 semanas

    Lima, Perú The Coca-Cola Company A tiempo completo

    We are accelerating our momentum as the fastest growing consumer goods company in Latin America. People are our focus when we collaborate with our diverse network of locally connected manufacturers and when we return every drop of water we use to communities and nature. **What You’ll Do for Us** - Leverage your scientific and regulatory expertise to...

  • Compliance/aml Specialist

    hace 4 semanas

    Lima, Perú Binance A tiempo completo

    Binance is the leading global blockchain ecosystem and cryptocurrency infrastructure provider whose suite of financial products includes the world’s largest digital-asset exchange. Our mission is to accelerate cryptocurrency adoption and increase the freedom of money. If you’re looking for a fast-paced, mission-driven organization where opportunities...

  • Remote Part-time Zoho CRM Specialist

    hace 4 semanas

    Lima, Perú ProcesosBilingues A tiempo completo

    Are you passionate about leveraging technology to drive business success? We're currently seeking a skilled Zoho CRM Specialist to join our team remotely. If you're fluent in both Spanish and English and have a knack for optimizing customer relationship management systems, we want to hear from you! **Responsibilities**: - Configure, customize, and maintain...

  • Associate, Database Administration

    hace 4 semanas

    Lima, Perú Kyndryl Peru SRL A tiempo completo

    **Why Kyndryl** Kyndryl is a market leader that thinks and acts like a start-up. We design, build, manage, and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward - always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our...

  • Safeguards Specialist

    hace 4 semanas

    Lima, Perú United Nations A tiempo completo

    **Job Opening** **Job Opening ID**: 222711 **Job Network** : Economic, Social and Development **Job Family** : Environmental Affairs **Category and Level** : Consultants, CON **Duty Station** : LIMA **Department/Office** : United Nations Environment Programme **Date Posted** : Nov 28, 2023 **Deadline** : Dec 11, 2023 **Result of Service** - The main...

  • Legal Assistant

    hace 1 mes

    Lima, Perú Kennedys Law A tiempo completo

    At Kennedys, we believe that we offer a great environment to build and grow your career in a Global firm. With our values at the core, we foster innovation and collaboration in a global setting. If you want to be a part of our distinctive culture and make a difference in the legal industry, we would love to hear from you. **Team** The Lima office is well...