Regulatory Affairs Specialist

4 semanas atrás

Sao Paulo, Brasil Edwards Lifesciences Tempo inteiro

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.
How you´ll make an impact

To ensure patients have access to innovative, high quality, safe and effective solutions to hemodynamic monitoring by obtaining Health Agency Medical Device approvals in compliance with local regulation Standards by being responsible of Regulatory Affairs activities within the respective country(ies).

Create regulatory submissions, for finalization and submission; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment in assigned countries/area of work (e.g., country clusters, Center of Excellence)

Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies.

Identify and develop moderately complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including executing all RA activities in Edwards systems to ensure compliant product distribution.

Identify trends, assess impact, analyze alternatives, and recommend action plans.

Participate in representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, and resolving conflicts between those requirements and development issues, and/or reporting to management.

Participate in providing guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement) including assessing impact to appropriate regulation

Review and approve promotional materials (e.g., collateral) from cross-functional teams

Manage local Establishment Regulatory Authorization, when applicable

Partner with CoE team in the Review of local generated promotional materials to comply with local regulatory requirements when needed

Interaction with QA for FCA & vigilance reports, Facilitate Q&As with local CAs for FCA, adverse events & vigilance reports

Assist with special projects on as -needed basis
What you will need

Bachelor's Degree in related field, 3 years experience previous related experience

Required in scientific discipline (e.g., Biology, Microbiology, Chemistry) Preferred

**Other**: Coursework, seminars, and/or other formal government and/or trade association training

Preferred Experience in preparing domestic and international product submissions

Advanced Portuguese and Spanish

Intermediate English

Knowledge of Brazilian regulation

This is a temporary position with possibilities of becoming fixed in the long term
What else will help you

Good medical writing skills

Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel

Good problem-solving, decision-making, organizational, analytical and critical thinking skills

Good written and verbal communication skills and interpersonal relationship skills

Ability to read, write and speak English required; Fluency in other language (e.g., German, French, Spanish, Italian, Portuguese, Russian, Polish) preferred

Solid knowledge and understanding of global regulations relevant to medical devices (e.g., Class I, Class II and/or Class III devices)

Solid knowledge and understanding of global regulatory requirements for new products or product changes.

Solid knowledge of new product development systems

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

Ability to build productive internal/external working relationships

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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