HireDiversity

Ciudad de México, MX

SR Regulatory Affairs Specialist Depuy - Synthes-000009I0

Description

"Johnson & Johnson companies are equal opportunity employers"

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: SR. Regulatory Affairs Specialist

General description:

Provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products. The individual may prepare and submit documentation needed for registration or may oversee such preparation. Also support of the product development process, submissions and regulatory compliance and assist with post-market review of product issues and other projects in domestic and international areas.

Main responsibilities:

· Prepares and/or supervises required local submissions with minimal supervision

· Provides assistance with establishment registration licenses.

· Coordinate information on several projects simultaneously.

· Interacts with other JJ personnel, government agencies in a professional, decisive, & articulate manner

· Supports regional team on product submissions schedules, prioritization and pipeline management

· Compliance Alerts support when regulatory agency report is needed

· Supervises the work of translation and dossier contractor

· Scans the external environment

· Represent J&J at local Ministry of Health meetings and external organizations.

· Selects and manages outsourced services providers (translation, regulatory, etc)

· Company Technical Responsible person in countries where required

· Prepares and leads training for RA Specialists and Associates

· Lead specific projects according local needs

· Able to provide strategic solutions to local RA team.

Reports to: Regulatory Affairs Manager

Cualificaciones

Qualifications

· A Bachelor's Degree in Chemical/Pharmaceutical/Medical

· 80% English language

· Good PC skills.

· Must have 5 - 7 years experience at least working in Regulatory Environment in Medical Devices Companies

Global Leadership Profile Competencies

Add: competencies accordingly from the list below:
- Strategic Thinking ~ driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; makes the customer central to all thinking; keeps the focus on driving customer value; motivated to leave things better than they were; a change agent
- 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
- Self-awareness and Adaptability ~ resilient; has personal modesty and humility; willing to learn from others; patient, optimistic, flexible and adaptable
- 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

Other Competencies and skills

Proactive

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