Vaga de Regulatory Affairs Specialist
1 vaga: | Publicada em 20/03
- A Combinar
Sobre a vaga
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
Completes and maintains regulatory approvals and clearances of assigned products.
Create regulatory submissions/playbook, exercising judgment to protect proprietary
information) 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, COE, Canada)
Identify and develop moderately complex Regulatory Affairs process improvement
initiatives including system enhancements, training, reports and/or dashboards
including executing all RA activites 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 regulations
Prepare documents for submissions, including assuring the appropriate forms for
all appropriate regulatory bodies
Review and approve materials (e.g., collateral) from cross-functional teams
Incidental:
Other duties as assigned by Management
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
Knowledge of other regulations in the region
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