HireDiversity

Ciudad de México, MX

Regulatory Affairs Specialist Depuy - Synthes-000009I1

Description

"Las Compañías de Johnson & Johnson ofrecen a todos los candidatos igualdad de oportunidades de empleo"

Company description:

Our companies of MD & D (Medical Devices & Diagnostics) provides treatment technologies in the areas of orthopedics, spine, sports medicine and neurology, sutures and tissue repair, biopharmaceutical, minimally invasive surgery, cardiovascular disease and diabetes care.

Searching the best talent for: Regulatory Affairs Specialist

General description:

Prepares proper submission for gathering market licenses as new product register, Changes and Renewals.

Supports RA Manager, to ensure submission plans on time.

Functions:
- Prepares required local submissions for New product registration, renewals & changes with a certain degree of supervision
- Follow up of other mandatory requirements for registration: local certifications, importation of samples and local testing, etc
- Represents the RA team in multifunctional projects/meetings.
- Regulatory review of promotional materials
- Prepares and approves labeling content
- Helps the work of translation and dossier contractor under the supervision of Sr. Specialist

Reports to: Regulatory Affairs Manager

Cualificaciones

Qualifications:

· A Bachelor's Degree in Chemical/Pharmaceutical/Medical Sciences or equivalent experience.

· 80% English

· Good PC skills.

· Must have 2-3 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions. Experience in Medical Devices industry..

Personal skills:

Proactive

Influence

Global Leadership Profile Competencies:

· Results and Performance Driven: assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent

· Intellectual Curiosity ~ sees the possibilities; willing to experiment; cultivates new ideas; comfortable with ambiguity and uncertainty

· Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed

· Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset

Ubicación principal: America Latina-México-Distrito Federal-Ciudad de México

Organización: Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)

Área: Coordinador de aprobaciones