Regulatory Affairs Specialist - Brazil

Purpose of the Role /

Key activities and accountabilities

• 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 Core and role specific 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 o 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)