Associate Regulatory Affairs Specialist, SEA - Toa Payoh

Benefit and Highlights:

• Great Place to Work ® Certified
• Attractive Employee Benefits
• Location : Buona Vista
• Reporting : Regulatory Affairs Manager, APAC

Main Objective:

Generates and manages submission documents for new products or changes to existing regulatory submissions.

Essential Duties and Responsibilities:

• 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

• 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

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

• 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

• 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
• Fresh graduates with strong interest in regulatory affairs are welcome to apply

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

• 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

Interested applicants are to apply online with us!