Job Details

ID #2778921
Estado Dakota del Sur
Ciudad Pierre
Full-time
Salario USD TBD TBD
Fuente J&J Family of Companies
Showed 2019-10-16
Fecha 2019-10-16
Fecha tope 2019-12-14
Categoría Etcétera
Crear un currículum vítae

REGULATORY SERVICES AND STRATEGY Specialist

Dakota del Sur, Pierre 00000 Pierre USA

Vacancy caducado!

At Johnson & Johnson Medical Devices Companies, we

are using our breadth, scale and experience to reimagine the way healthcare is

delivered and help people live longer, healthier lives. As pioneers in medical

devices, we continually focus on elevating the standard of care—working to

expand patient access, improve outcomes, reduce health system costs and drive

value. We create smart, people-centered healthcare to help the patients we

serve recover faster and live longer and more vibrantly.In a healthcare

trajectory changing, JJMD regulatory Affairs (EMEA) is looking for a Regulatory

Services & Strategy Specialist for its Ethicon and CSS portfolio.REGULATORY SERVICES AND STRATEGY Specialist – ETHICON/CSSJob Summary

Responsible of building

and maintaining the business integration/Divestiture process in collaboration

with EMEAC Local Operating Companies and the RSS Associate Director.

Establish a solid

Regulatory Intelligence Process with a close collaboration with the Regulatory

Policy organization to monitor and provide a comprehensive understanding to all

stakeholders who are engaged with the regulatory intelligence

Lead and monitor the

regulatory implementation plan to meet timelines and ensure compliance

Provide support to RRS

Leads in their cycle plan management

Drive communication and

collaboration between BQ, RA Policy, SC Franchises and LOCs

Provide support to RSS

Leads to ensure timely delivery of documentation for registration and renewals.

Provide support to LOCs

for specific and strategic tenders

Main Responsabilities

Provides advice and

counsel to the franchise & LOCs regarding the Regulation in each EMEAC

country and works closely with them to ensure full alignment between the local

and the global teams

Partners with RSS team

to translate processes and the portfolio strategy into executable regulatory

plans on a project-by-project basis

Stays abreast of all

pertinent regulatory affairs environment changes so as to inform the BU

Provides direction on

EMEAC regulations that impact product access to the market

Analyzes complex

regulatory schemes & offer Clear mapping to stakeholders who are involved

in the process

Liaises with the RSS

Leads to understand which products would be impacted by any new regulation to

provide insights and direction

Analyzes the dashboard

metrics that pertain to the RSS organization team and escalates to the

different forums as appropriate when issues are identified

MDRIM – Guarantee that

the strategies for newly regulated countries and duly assigned to the

corresponding LOC per the plan

Competencies

Must have excellent

written, verbal communication and presentation skills.

Conflict Management

Ability to interface

successfully with all levels of internal organization (including senior

management)

Strong analytical skills

Strategic planning

Must be able to

communicate clearly, succinctly and effectively over the phone and in writing.

Solid interpersonal

skills including the ability to remain calm, professional, diplomatic, and

positive.

Must be able to work in

a timeline-driven environment.

Analytical skills to

understand global markets and to solve complex problems quickly

GLP Behaviors

Integrity & Credo-based

Actions

Results & Performance

Driven

Sense of Urgency

Strategic Thinking

Intellectual curiosity

Collaboration and teaming

Self-awareness and adaptability

Big Picture Orientation

QualificationsExperience Requirements

At least 4 years of

medical device, diagnostic or related industry experience.

Experience shall include

relationship building, negotiation, management and a proven track record of

strategic thinking.

Demonstrated expertise

and knowledge and understanding of Regional (EMEAC), US and international

medical device landscape.

Demonstrated ability to

set effective business model and related technical tools to support.

Demonstrated experience

of managing multiple projects simultaneously and consisting of varying degrees

of complexity.

Education Requirements

Bachelor’s degree or equivalent experience. Master’s degree preferable

Strong computer and system data management skills

Fluent in English – Written and Spoken

Primary LocationFrance-Haute-de-Seine-Issy Les Moulineaux-Other LocationsEurope/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Italy, Europe/Middle East/Africa-Portugal, North America-United States, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-GreeceOrganizationEthicon S.A.S. (7840)Job FunctionRegulatory AffairsRequisition ID00003B

Vacancy caducado!

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