Job Title Especialista Assuntos Regulatórios Job Description Experienced Regulatory Affairs SpecialistThis position will coordinate Regulatory Affairs activities in Brazil, managing 100 product licenses, including updates, renewals, and new registrations.
Responsibilities include executing regulatory strategies for new product introductions and lifecycle products, compiling and submitting applications to regulatory agencies, and interacting with commercial and regulatory partners to expedite submissions and approvals.
The role requires collaboration with management and cross-functional partners to implement regulatory strategies and ensure compliance.Your role:Serving as the subject matter expert on regulatory affairs between manufacturers and internal and external stakeholders in Brazil.Communicating timely and accurately on Brazil-specific regulatory requirements and advising business partners/product design teams of regulatory strategy and requirements.Implementing global regulatory strategies and roadmaps through understanding competitive market landscape and product marketing strategies.Preparing regulatory submissions for new products/solutions, product changes, and re-registrations as required for Brazil.Planning and maintaining registration information and obtaining re-registration approvals in advance of license expirations to ensure no disruption in product availability.Being the subject matter expert and key point of contact for communication with Regulatory Affairs activities related to Brazil regulators, trade associations, and Competent Authorities.Maintaining and organizing appropriate regulatory records to demonstrate compliance with applicable regulations in Brazil and LATAM.Supporting development of regulatory plans, risk assessments, and required activities to meet regulatory requirements and product registrations to maintain compliance.Acting as an advisor cross-functionally to meet schedules and/or solve technical questions.You're the right fit if:You have acquired a minimum of 5 years of experience in Regulatory Affairs in Medical Devices, including experience with interacting with local Trade-Associations, Competent Authorities, and Notified Bodies (Anvisa).Your skills include Advanced English level, strong communication skills, influencing skills, as well as being organized, detail-oriented, and possessing strong decision-making skills.You hold a bachelor's degree (Technical/Engineering or Medical, Biomedical).How we work togetherWe believe that we are better together than apart.
For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company's facilities.
Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
This role is an office role.About PhilipsWe are a health technology company.
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