Kerja Sepenuh Masa Associate Regulatory Affairs Specialist SEA, Gaji tinggi SGD 4,000 di ARTHREX SINGAPORE, PTE. LTD. West Region (Singapore) - Maukerja

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Main Objective:

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.

Essential Duties and Responsibilities:

       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

       RA Compliance and Document Control

     Regularly maintaining and updating product registration and listing databases for the assigned country

     Implementing change control for already-approved products including regulatory submissions

     Collecting and assessing product change information to take necessary actions

       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

Education and Experience:

       Degree qualified preferably in a Science or Engineering discipline

       Minimum 1-2 years direct RA experience within a medical device company

Knowledge and Skill Requirements/Specialised Courses and/or Training:

       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 both independently and as part of a team to effectively contribute in both individual and collaborative settings

       Ability to manage multiple tasks and prioritize work in a dynamic, fast paced environment

       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