Regulatory Affairs Specialist

Há 3 dias

Sao Paulo, Brasil Serviap Group Tempo inteiro

Responsible for planning and implementing the strategy for medical devices registration activities for clients
- Support in responding to RFPs for regional regulatory projects
- Responsible for planning, executing, and coordinating all regulatory activities including major lifecycle maintenance and customer’s market expansion activities
- Able to manage the end-to-end process of registration of Medical Devices/IVDs with various internal departments, external consultants as well as HAs, and to provide/coordinate guidance and insights throughout the process
- Responsible for handling Mexican Registration Holder (MRH) activities for Medical Devices/IVDs.
- Support with any local testing, GMP, and/or any other mandatory requirements for Medical Devices/IVDs approval.
- Responsible for delivery of regulatory projects, programs, and solutions for all regional customer opportunities
- Responsible for ‘Requests for Proposals’ (RFPs), project evaluations, etc.
- Cross functional ownership of regulatory projects including project evaluation, solutioning and delivery
- Provide and act on local/regional regulatory intelligence by responding to significant changes in the regional regulatory environment and communicating the impact appropriately among stakeholders
- Supports business growth initiatives (e.g., marketing & sales) in collaboration with business leadership, to meet business targets
- Provides competitive intelligence for the country
- e.g., local in-country provider competition (cost comparison, skillsets, specialization, history)
- Local market/region criteria
**EXPERIENCE**:
At least 6 to 8 years of industry experience, with experience in a global regulatory affairs role including regulatory strategy, planning and execution for the new devices in the country.
- Experience across all risk classes of Medical Devices, as well as IVDs.
- Support the project delivery team and other stakeholders with Mexico-based client projects.
- Strong understanding of the regulatory framework for medical devices registration, including approval processes.
**Education**:
- University Degree (or higher) in life sciences domain or in health sciences or pharmaceutical sciences

**Skills**:
- Strong command of English and Spanish, interpersonal communication and writing skills (additional language skills would be beneficial). Competency in at least one language of the region would be an added advantage
- Experience in regulatory related business strategy and demonstrated ability in driving business growth, through regulatory projects
- Flexible, and self-driven
- Experience of working with large, dynamic, and culturally diverse teams
- Standard skills as those expected from an experienced regulatory professional
- Ability to represent the organization at workshops/seminars/conferences or promotional events would be an added advantage

**Salary**: R$11,994.00 - R$14,600.00 per month

  • Regulatory Specialist

    2 semanas atrás

    São Paulo, Brasil EBANX Tempo inteiro

    Build your future with Sovos. If you\'re seeking a career where innovation meets impact, you\'ve come to the right place. As a global leader, Sovos is transforming tax compliance from a business requirement to a force for growth while revolutionizing how businesses navigate the e... Regulatory Affairs Specialist We are seeking a Regulatory Affairs...

  • Regulatory Affairs Specialist

    Há 7 dias

    São Paulo, São Paulo, Brasil ICON plc Tempo inteiro R$60.000 - R$120.000 por ano

    Regulatory Affairs Specialist Post Register - Home based - São PauloICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a...

  • Senior Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, Brasil Monster Energy Tempo inteiro

    OverviewSenior Regulatory Affairs Specialist at Monster Energy. The role focuses on registrations and compliance for raw materials and finished products, and collaboration with regulatory leaders and the regional NPD team to support product registrations and labeling in dynamic markets. The Day In The LifeAs a Sr Specialist in Regulatory Affairs, you will...

  • Senior Regulatory Affairs Specialist

    3 semanas atrás

    São Paulo, Brasil Monster Energy Tempo inteiro

    Overview Senior Regulatory Affairs Specialist at Monster Energy. The role focuses on registrations and compliance for raw materials and finished products, and collaboration with regulatory leaders and the regional NPD team to support product registrations and labeling in dynamic markets. The Day In The Life As a Sr Specialist in Regulatory Affairs, you will...

  • Regulatory Affairs Project Management Specialist

    Há 3 dias

    Sao Paulo, Brasil Johnson & Johnson Tempo inteiro

    **REGULATORY AFFAIRS PROJECT MANAGEMENT SPECIALIST**: At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1...

  • Regulatory Affairs Analyst

    Há 5 dias

    Sao Paulo, Brasil MSD Tempo inteiro

    **Job Description**: **SUMMARY** The Associate Specialist, Regulatory Affairs supports a variety of regulatory and cross-functional initiatives and executes/ tracks all activities associated to different types of regulatory submissions and products, in collaboration with internal and external stakeholders, following global and local strategies and oriented...

  • Regulatory Affairs Sr Specialist

    Há 2 dias

    Sao Paulo, Brasil Johnson & Johnson Tempo inteiro

    **REGULATORY AFFAIRS SR SPECIALIST - LATAM** At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion...

  • Regulatory Affairs Specialist

    2 semanas atrás

    São Paulo, Brasil Johnson & Johnson Tempo inteiro

    **Job Function**: Regulatory Affairs Group **Job Sub Function**: Regulatory Affairs **Job Category**: Professional **All Job Posting Locations**: São Paulo, Brazil Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing...

  • Regulatory Affairs Manager

    2 semanas atrás

    Sao Paulo, Brasil Unilever Tempo inteiro

    **Unilever is currently hiring for a Regulatory Affairs Manager based in São Paulo.** **Unilever** is the place where you can bring your purpose to life with the work that you do - creating a better business and a better world. We are looking for talents that would like to join this exciting journey with us. Our **R&D Brazil Beauty & Wellbeing** team is...

  • Sr Specialist Regulatory Affairs

    Há 2 dias

    Sao Paulo, Brasil QIAGEN Tempo inteiro

    At the heart of QIAGEN’s business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. Our...