Johnson & Johnson Careers
Regulatory Affairs Associate
Requisition ID: 1805682866W
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.
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
- 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)
"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"
Mexico-Distrito Federal-Mexico City
Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)