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Job Details

  • Title:
    Regulatory Affairs Specialist, SEA
  • City:
    Singapore
  • Country:
    Singapore
  • Company:
    Arthrex SEA

Description

Benefits & Highlights:

 

  • Work Style: Hybrid/Flex
  • Location: Buona Vista
  • Great employee benefit
  • Weekly office lunches
  • Reporting Line: Regulatory Manager, APAC

 

About the Role: -

Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements. Staying abreast with regulatory compliance requirements and changes affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions.

Change Assessments (RA Compliance and Document Control)

    • Supporting the review of change assessments to provide regulatory impact and associated information to the global change management team.
    • Supporting the preparation of submission dossiers for reportable changes.
    • Supporting the management and maintenance of change information.

Regulatory Affairs (RA) Submissions and Applications

      • Writing, preparing, submitting regulatory documents for the South-East Asia (SEA) market (Arthrex distributor and subsidiary)
      • Communicating with regulators on submission projects
      • Prioritising and organising multiples projects with competing priorities
      • Participating in regulatory affairs planning for SEA markets
      • Providing support in APAC level projects as and when needed
      • Reviewing product labelling and Directions for Use (DFU), if any translation is required

Ongoing Education and Training

    • Proactively attending seminars, lectures and academic conferences to continuously develop skills and to collect and share insights

Regulatory Intelligence

    • Keeping abreast with the latest regulatory updates within SEA relating to Arthrex products and ensuring Arthrex as a company is aware, ready and able to comply with the necessary changes
    • Providing input to change management projects for global regulatory change assessments
    • Participating and providing support in cross-functional collaboration on new product and country launches

Product Recall and Complaint Support

    • Supporting product safety alert activities and field actions
    • Assisting in activities relating to post market surveillance (i.e. Complaints, Performance Evaluation Reporting (PER), Adverse Event Reporting (AER), and/or liaising with Regulatory bodies in assigned countries)
    • Participating in both internal and external quality system audits

 

Requirements

Education and Experince :

  • Degree qualified preferably in a Science or Engineering discipline
  • Minimum 1-2 years direct RA experience within a medical device company
  • Strong working knowledge of SEA medical device regulations and standards
  • Knowledge of global regulations will be advantageous
  • Excellent interpersonal skills, with proven ability to effectively communicate and form strong relationships with stakeholders across all levels
  • Ability to work in fast paced environment and handle multiple tasks and requests
  • Comprehension of technical, engineering or medical terminology, and/or ability to reference literature for understanding
  • Technical skills in manufacturing or design relating to regulatory affairs will be advantageous

 

About Arthrex

Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.