Regulatory Affairs Assistant

ASUNTOS REGULATORIOS / REGULATORY AFFAIRS

Entry-Level Position / Puesto de Entrada

Experience:
6 months to 1 year in Medical Devices regulatory affairs (including time as trainee/practicante)

Location:
Hybrid (Office in Lima, Peru) / Remote + Office in Lima, Peru

About Us:

We are a small yet innovative Peruvian firm that provides comprehensive regulatory affairs solutions and complementary services for the Latin America region, with a special focus on the smaller, somehow underserved, markets.

We primarily serve the biotechnology, pharmaceutical, and medical device industries but have led successful projects for cosmetics and foods and supplements.

Most of the services we provide are related to marketing approvals (
registros sanitarios
) and lifecycle management activities in the region, with more than 90% of our submissions made outside of Perú.

The company also provides Regulatory Intelligence, Regulatory Consulting, Regulatory Strategy and Patient Safety services.

RAFINT is ISO 9001:2015 certified.

Position Overview:

We are looking to fill one (1) position within our medical devices team at the level of Junior Regulatory Affairs Assistant (RAA Jr.) or Regulatory Affairs Assistant (RAA).

The ideal candidate will have 6 months to 1 year of experience in regulatory affairs for medical devices (
including time spent as a trainee in a related role)
, with hands-on experience in managing and submitting initial approvals and/or product variations.

We are looking for candidates who are eager to develop professionally with us.

The position may be required to perform task to support regulatory intelligence activities and initiatives.

What We're Looking For:

Candidate Profile

• Language Proficiency:
  High-intermediate to advanced level of English.
  
  Proficiency in English is essential as it is the primary language for client communication.
  
  Spanish is used for internal communication.
  
  
• Educational Background:
  Bachelor's degree in pharmacy or a closely related field.
  
  This position is not suitable for law professionals.
  
  
• Experience:
  As outlined above.
  
  In exceptional cases, formal training in regulatory affairs may be considered in lieu of direct experience.
  
  
• Computer Skills:
  Proficiency with productivity applications and general computer literacy is very important.
  
  We make extensive use of MS Office applications, SharePoint, and our own internal RIMS database.
  
  
• Adaptability:
  We seek proactive candidates who can quickly adapt to changes in a dynamic environment.
  
  As a small business, we value agility and the ability to work with diverse client cultures.
  
  
• Communication Skills:
  Strong oral and written communication skills are essential, as is the ability to interpret complex written information.
  
  While guided training is provided, a significant amount of self-learning is expected, making strong reading comprehension abilities critical.
  
  
• Learning Attitude:
  A demonstrated ability and attitude to learn quickly.
  
  
• Integrity and Accountability:
  Candidates must show a strong sense of integrity and accountability, both internally and externally.