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

Change Assessments (RA Compliance and Document Control)

Performing review of change assessments to provide regulatory impact and associated information to the global change management team
Maintaining accurate and complete change information to demonstrate traceability of changes
Preparing and compiling submission dossiers for reportable changes
Acting as primary contact regarding changes and ensure changes are understood by relevant stakeholders

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 an Engineering or Science discipline
1-2 years of direct RA experience within a medical device company preferred
Fresh graduates are welcome to apply

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Associate Regulatory Affairs Specialist SEA