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!