Regulatory Affairs Lead Specialist - Medical Devices

Johnson & Johnson Family Of Companies; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A major healthcare and medical devices firm based in São Paulo is seeking a Regulatory Affairs professional with over 4 years of experience in the regulatory environment. The ideal candidate will coordinate submissions, manage consulting services, and ensure compliance with local and international regulations. A Bachelor's degree in life sciences is required, alongside strong communication and project management skills. Fluency in English and Portuguese is essential for this role.

Qualificações

• Must have at least 4 years of experience in Regulatory Environment.
• Experience in preparing submissions for complex devices.
• Bi-lingual: Fluent in English and Portuguese.

Responsabilidades

• Coordinate work of RA Specialists for timely submissions.
• Manage external consulting services for regulatory files.
• Prepare and submit regulatory documents to MoH.

Conhecimentos

Regulatory compliance

Project management

Technical expertise

Communication skills

Team collaboration

Formação académica

Bachelor's Degree in Engineering, Pharmacy, or other life sciences

Advanced Degree preferred

Ferramentas

Regulatory Databases

Advanced PC skills

Descrição da oferta de emprego

Responsibilities

• Coordinates the work of RA Specialists to ensure submission is done properly and in timely manner
• Selects and manages external consulting services to prepare files in same conditions than internal as needed
• Supports regional team on product submissions schedules, prioritization, and pipeline management.
• Supports regional team on requests and follow-up of documentation provided by OCs to prepare registration dossiers
• Act as liaison for franchises to support business plans and regulatory needs
• Serves as a technical expert within job function
• Prepare and lead training for RA Specialists
• Propose innovative strategies / solutions for technical files and submission to fulfill requirements and be in compliance with regulatory agency requirements
• Participate in multifunctional teams to establish regulatory strategic plans with mínimal guidance
• Assist in the development and implementation of regulatory strategies with team representatives and with the Regulatory Affairs Manager.
• Prepare and submit proper regulatory documents and technical files to MoH with mínimal supervision
• Prepare alert communications according to registration process progress and findings during this
• Lead specific projects / requests to ensure alignment with business goals and timely responses
• Coordinate information on several projects simultaneously
• Interacts with other JJ personnel, government agencies in a professional, decisive, & articulate manner.
• Scan and influence the external environment.
• Represent J&J at Local MoH meetings and external organizations
• Provide assistance with establishment registration licenses.
• Coordinate / assist in the review and analysis of market licenses and labeling to set up product codes status
• Ensure that Regulatory Databases and Labeling Databases are well updated as per submissions and approvals received
• May identify and communicate new regulatory / legal requirements
• Support franchise, bids and functional areas consultations to clarify regulatory questions / conditions
• Actively participation and timely delivery results in RA teams to achieve common goals or attend common strategies
• Adhere to company and regulatory bodies' policies and procedures regarding product introductions, changes and labeling

Qualifications

Must have at least 4 years of experience working in Regulatory Environment (and / or training or equivalent combination of education and experience), preparing submissions for complex devices and a successful track record.

Desirable experience in Medical Devices, Pharma background is acceptable.

A Bachelor's Degree in Engineering, Pharmacy or other life science : Can be a person with related experience and / or training or equivalent combination of education and experience.

Experience with people management is desirable.

Education in Engineering or Biomedicine is desirable

Knowledge of Local & International Regulation and Processes

Advanced Degree preferred.

Bi-lingual: Fluent English - local language (Portuguese)

Advanced PC skills

Location

Brazil-São Paulo-São Paulo

Organization

J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda.

Job Function

Regulatory Affairs