Associate Regulatory Affairs Specialist, SEA

ARTHREX SINGAPORE, PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading company in the healthcare industry is seeking a Regulatory Affairs professional responsible for ensuring submissions meet compliance requirements in the South-East Asia market. The role involves coordinating between regulators and internal teams while maintaining product registrations and contributing to regulatory intelligence. Fresh graduates who meet the degree requirements are encouraged to apply.

Benefits

Great Place to Work Certified

Attractive Employee Benefits

Qualifications

• Degree qualified preferably in a Science or Engineering discipline.
• Fresh graduates with strong interest in regulatory affairs are welcome to apply.

Responsibilities

• Writing and submitting regulatory documents for the South-East Asia market.
• Maintaining product registration and listing databases.
• Supporting product safety alert activities and product recalls.

Skills

Interpersonal Skills

Knowledge of Global Regulations

Technical Comprehension

Education

Degree in Science or Engineering

Job description

Benefit and Highlights:

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

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
• 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!