Johnson & Johnson Careers

Regional Safety Officer, Medical Devices, Asia Pacific

Singapore, Singapore
Quality Assurance


Job Description

Requisition ID: 1905731972W

The Regional Safety Officer (RSO), Medical Devices, APAC, is the Senior Safety leader for Medical Devices for the AP Region.
The RSO, APAC, will:
  • Oversee the Medical Devices Safety Strategy in the region while maintaining highest level of compliance with local regulations and JNJ global policies.
  • Be the face of Medical Device Medical Safety in the region and ensure the Global Medical Device Medical Safety strategy is translated and deployed on a regional and local level.
  • Lead and execute the continuous development and implementation of TRUST- Support (Timely and Relevant Use-related Safety Training-Support).
  • Address any emerging safety concerns related to Medical Devices in the region.
  • Lead the AP Medical Devices Safety efforts in strong collaboration with Regional Medical Affairs and build strong networks and collaborations with regional and local operating company leaders.
  • Partners with Global/ Regional/ Country Epidemiology teams to drive safety surveillance work for Medical Devices.
  • Engage with the relevant external organizations to build relationships that will further develop and enhance the Global and Regional Safety Risk Management Strategy and Policy for Medical Device Safety.
  • Serve as a key interface between global functions, regional leadership and the local operating companies (LOCs) for Medical Device Safety.
  • On request, provide input into Safety Surveillance Plans and Regional Risk Management Plans (if any).
  • On request, provide input into applicable local safety policy and strategy. 
  • On request, provide input into AE reviews, in collaboration with country/cluster Medical Director.
  • Partners with  Regional Quality Leads to ensure local/regional policies and procedures regarding medical safety are appropriate and align with Enterprise and Sector Standards
  • Partners with Regional Quality Leads to ensure local company handling processes are appropriate with regard to trending and tracking, periodic medical safety review and input, and MDR/AE review, reporting and escalation as required.
  • Serves as a member of the AP Regional Medical Affairs Leadership Team.
  • Serves as a key partner to the regional Global Education Solutions (GES) Team.
  • Develop Regional Medical Safety Talent that supports the AP Medical Community.
PRINCIPAL RESPONSIBILITIES: 
  • Lead the AP Medical Devices Safety efforts in strong collaboration with Regional Medical Affairs and build strong networks and collaborations with regional and local operating company leaders. Partners with Regional Quality Leads to ensure local company handling processes are appropriate with regard to trending and tracking, periodic medical safety review and input, and MDR/AE review, reporting and escalation as required. Proactively address any emerging safety concerns related to Medical Devices in the region.
  • Lead and execute the continuous development and implementation of TRUST- Support (Timely and Relevant Use-related Safety Training-Support) via direct partnership with Medical Affairs, Global Education Solutions, Marketing and Sales, Quality and any other relevant stakeholders.
  • Lead the AP Medical Devices Safety efforts in strong collaboration with Regional Medical Affairs and build strong networks and collaborations with regional and local operating company leaders.
  • Engage with the relevant external organizations to build relationships that will further develop and enhance the Global and Regional Safety Risk Management Strategy and Policy for Medical Device Safety.
  • Serves as a member of the AP Regional Leadership Team and a member of the AP Medical Affairs Leadership Team.
  • Develop Regional Medical Safety Talent that supports the AP Medical Community
REPORTING RELATIONSHIPS:  

Reports directly into the Head, International Safety Risk Management and Policy. 
APAC Medical Device Medical Directors will have a dotted line reporting for Safety matters, into the RSO, Medical Devices, APAC.

Qualifications

DECISION-MAKING AND PROBLEM-SOLVING:

Senior level independent as well as collaborative decision making with internal and external business partners including Commercial, R&D, Medical Affairs, Quality, Regulatory and other safety colleagues, in subject matters including regional and local cluster product safety strategy, issue management and process excellence.
Implements and monitors Regional Medical Device TRUST-Support Strategy in conjunction with regional cross-functional leaders

EDUCATION & EXPERIENCE REQUIREMENTS: 

A Doctor of Medicine, (MD), Doctor of Osteopathy (DO). designation or equivalent, such as MBChB is required

Required:
  • A minimum of 6 to 8 years clinical experience
  • Experience in risk evaluation and mitigation
  • Strong leadership skills
  • Very strong collaboration skills
  • Medical device and/or pharmaceutical industry experience
Desirable:
  • A minimum of 3 years’ experience in risk evaluation and mitigation
  • Direct  working experience in a country outside the US
  • Experience of interfacing with senior leadership within a global healthcare company

Primary Location
Singapore-Singapore-Singapore-
Other Locations
Asia Pacific
Organization
Johnson & Johnson Pte. Ltd. (8435)
Job Function
Quality Assurance
Requisition ID
1905731972W