Commercial Regulatory Affair & Project Lead, 12 Month, Cbd

Singapore, Singapore

Job Description


Job Summary:

  • Coordinate and manage all related RA activities for the portfolio in Singapore
  • Act as a RA Project Manager for APAC regional projects
Job Scope:
Commercial RA Singapore role
  • Responsible for pre-market submission and post-market surveillance management of IVD medical device products for SG Affiliate
  • Support and develop regulatory submission plan for the region in collaboration with project team, manufacturing sites, supply chain, marketing and country manager
  • Work closely with relevant manufacturing sites and other functions to obtain all the necessary documents to support product registration, renewal or amendment to existing product certificates
  • Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders.
  • Responsible for review of promotional material for Singapore
  • Track regulatory milestones in internal Regulatory database
  • Report submission status via defined Key Performance Indicators
APAC Regulatory Project Lead
  • Lead and support APAC region team on assigned projects (e.g. change notification, rebranding, site transfer, NPIs).
  • Track and maintain status of APAC regional projects by working closely with country Regulatory teams.
  • Share project status to identified stakeholders on a regular basis with appropriate scorecards.
  • Ensure timely execution of regulatory strategies as per plan, identify risk at an early stage and develop mitigation plans as needed
General
  • Represents RA and/or APAC at relevant meetings
  • Support strategic Quality and Regulatory Affairs Goals and objectives
Job Requirement:
  • BSc or equivalent, minimum of 5 years\' experience in Regulatory Affairs in Medical Devices, ideally in IVDs
  • Demonstrable working knowledge of the medical diagnostics industry, including Software as a Medical Device (SaMD).
  • Knowledge of and demonstrated experience in IVD Medical devices registration for Singapore
  • Project management and able to navigate in a cross functional environment
  • Knowledge of the APAC regulatory environment, including SaMD US FDA and regional digital health regulations and requirements, legislation, industry standards and guidance
  • Written and oral communication skills and attention to detail
  • Interpersonal skills, highest levels of integrity and diplomacy.
  • Capacity to maintain the highest levels of confidentiality. internally and externally
Additional Information:
  • Salary - Open for discussion
  • Contract duration: 12-month contract, renewable
  • Commencement Date: Immediate
  • Working days and hours: Mon to Friday, 9am to 6pm
  • Location: Bugis, DUO Tower
Lyn, Yee Chen Fu EA License No. 02C3423 Personnel Registration No. R1110796

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Job Detail

  • Job Id
    JD1303422
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    $6500 - 7500 per month
  • Employment Status
    Permanent
  • Job Location
    Singapore, Singapore
  • Education
    Not mentioned