Regulatory Affairs Specialist - Brazil

Rayner Surgical Group; Brasil; Presencial; BRL 111 600 - 167 400; Tempo integral

Resumo da oferta

A leading medical devices company in Brazil is looking for a Regulatory Affairs professional to support registration activities. The role includes developing registration plans, ensuring compliance with local regulations, and interfacing with regulatory agencies. Ideal candidates will have 3-5 years of regulatory experience in medical devices, along with fluency in Portuguese and English. Strong communication and teamwork skills are essential for success in this dynamic environment.

Qualificações

• 3-5 years’ experience in a Regulatory role in a medical devices company.
• Direct interaction with regulatory authorities (ANVISA, Government Agencies).
• Fluent in Portuguese and English (verbal and written).

Responsabilidades

• Develop registration and launch plans with regional sales managers.
• Prepare and submit registration dossiers.
• Ensure compliance with Brazilian Licence Holder and BGMP requirements.
• Interface with regulatory agencies and support inspections and audits.

Conhecimentos

External Awareness

Adaptability

Communication

Decisiveness

Teamwork

Formação académica

Degree in a science, clinical or engineering subject

Equivalent experience in a medical device environment

Descrição da oferta de emprego

Overview

Provide support for registration activity in your assigned geographic region(s); this includes (but is not limited to):

• Developing registration and launch plans with the regional sales managers.
• Preparation and submission of registration dossiers, and their remediation.
• Ensure compliance with Brazilian Licence Holder and BGMP requirements.
• Establish and maintain regulatory information systems such as technical documentation, quality records, routine reports and regulatory agency communications.
• Interpret existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures.
• Ensure compliance to global regulatory requirements and company policies.
• Provide input to Company activities including the risk management process, process and procedure improvements, management review and support new product development activities
• Review document and product changes for regulatory submission impact.
• Support equipment, system and process development in-house and with suppliers.
• Interface and co-ordinate with regulatory agencies; provide regulatory input and appropriate follow-up support to inspections and audits (e.g. ANVISA etc)
• Participate on product development teams to ensure regulatory requirements are incorporated into the development process

All such other tasks as may be reasonably required to support the activities of the Regulatory Affairs department and the Company

Competencies

• External Awareness: Understands and keeps up to date on local, national, and international policies and trends that affect the organization and shape stakeholders' views; is aware of the organisation's impact on the external environment
• Adaptability: Adjusts to changing environments whilst maintaining effectiveness
• Communication: Communicates effectively, listens sensitively, adapts communication to audience and fosters effective communication with others
• Decisiveness: Makes well-informed, effective, and timely decisions, even when data are limited, or solutions produce unpleasant consequences; perceives the impact and implications of decisions.
• Teamwork: Contributes fully to the team effort and plays an integral part in the smooth running of teams without necessarily taking the lead Organisational Awareness: Demonstrates an understanding of underlying organisational issues

Qualifications

Essential

• 3-5 years’ experience in a Regulatory role in a medical devices company – including direct interaction with regulatory authorities (ANVISA, Competent Authorities, Government Agencies etc.)
• Either: A degree in a science, clinical or engineering subject or Equivalent experience achieved through working in a medical device or a medical environment for 3-5 years
• Experienced in the requirements of Quality System concepts, practices and procedures (e.g. MDSAP, ISO 13485, BGMP)
• Experienced with the requirements of ANVISA regulations
• Fluent Portuguese (verbal and written)
• Fluent English (verbal and written)

Desirable

• Fluent Spanish (verbal and written)