Johnson & Johnson Careers

Regulatory Affairs Associate

Mexico City, Mexico
Regulatory Affairs


Job Description

Requisition ID: 1805682866W

Medical Devices Segment- Johnson Medical
 

Our Medical Devices business segment produces a broad range of innovative products and solutions used primarily by health care professionals in the fields of orthopedics, neurological disease, vision care, infection prevention, cardiovascular disease, and aesthetics.

 
Regulatory Affairs Associate
 
 

Duties & Responsibilities:

 
  • Coordinates, compiles, and submits new drug applications, abbreviated new drug applications and investigational new drug applications, Medical device regulatory submissions, to the regulatory agencies
  • Assists with ensuring compliance with regulatory agency regulations and interpretations
  • Assists with the preparation of responses to regulatory agencies such as INVIMA, Cofepris questions and other correspondence
  • Assists with organizing and maintaining reporting schedules for new drug application and investigational new drug applications
  • Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
  • Provides solutions to a variety of problems of limited scope and complexity
  • Conducts searches of existing files for requested information
  • Maintains and archives all regulatory documentation


Qualifications
Qualifications:
 
  • Education level required: Bachelor’s in Sciences, Pharmacist, Engineering
  • Years of Experience: 0-2 years
  • Required Experience:

Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions. Desirable experience in Medical Devices, Pharma.

  • Required knowledge: 

Oriented to details, good written and verbal communication skills, and planning skills. Flexible to changes.

  • Travel percentage: 10%
  • Language: Spanish and English (Advance)
 
 
Location of the role: Mexico City
 
 

"In Johnson & Johnson we recognize that differences in age, race, gender, nationality, sexual orientation, physical ability, thinking style and background bring richness to our work environments. Such differences help us connect better with the health needs of people in communities around the world.

 

We believe that attracting, developing and retaining a base of employees that reflects the diversity of our customers is critical to our success. We also believe success hinges on relationships with diverse professional and patient organizations, civic groups and suppliers.

 

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status"



Primary Location
Mexico-Distrito Federal-Mexico City
Organization
Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)
Job Function
Regulatory Affairs
Requisition ID
1805682866W