Regulatory Affairs Specialist

Há 6 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

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