Boston Scientific Regulatory Affairs Specialist II 

Argentina, Autonomous City of Buenos Aires, Buenos Aires 

628295946

About the role

• Develop local strategies for regulatory approval in collaboration with Marketing, Planning and International Division teams.
• Coordinate, compile and submit regulatory submissions for new products, revalidations and modifications to ANMAT.
• Consolidate documentary packages to send to Bolivia, Paraguay and Uruguay.
• Review product changes and assess their regulatory impact.
• Review promotional materials.
• Represent Regulatory Affairs in cross-functional projects, providing regulatory feedback and guidance, including participation in process changes, continuous improvement efforts and acceleration towards digital transformation.

Required Qualifications

• Level of education required: University degree or advanced student in Pharmacy, Biochemistry, Health Technology, Biomedical Engineering or related fields
• Languages and level achieved: Advanced English
• Experience in Medical Device Regulatory Affairs. 3 – 4 years

Preferred Qualifications

• Organized, able to follow established processes.
• Ability to manage databases in software and systems.
• Effective communication of complex ideas, both verbally and in writing, good writing skills.
• Team player with excellent interpersonal skills and strong problem-solving skills