Associate Regulatory Affairs Specialist, SEA

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:

• Prepare and submit regulatory documents for the SEA market (Arthrex distributor and subsidiary).
• Communicate with regulators on submission projects.
• Prioritize and manage multiple projects with competing priorities.
• Participate in regulatory planning for SEA markets.
• Support APAC-level projects as needed.
• Review product labeling and Directions for Use (DFU), including translations if required.

RA Compliance and Document Control:

• Maintain and update product registration and listing databases.
• Implement change control for approved products, including regulatory submissions.
• Collect and assess product change information for necessary actions.

Ongoing Education and Training:

• Attend seminars, lectures, and academic conferences to develop skills and share insights.

Regulatory Intelligence:

• Stay updated on regulatory changes in SEA for Arthrex products.
• Provide input for global regulatory change assessments.
• Support cross-functional collaboration on new product and country launches.

Product Recall and Complaint Support:

• Support product safety alerts and field actions.
• Assist in post-market surveillance activities (complaints, PER, AER) and liaise with regulatory bodies.
• Participate in 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/Specialized Courses and/or Training:

• Strong knowledge of SEA medical device regulations and standards.
• Knowledge of global regulations is advantageous.
• Excellent interpersonal skills for effective communication and relationship-building with stakeholders.
• Ability to work in a fast-paced environment and handle multiple tasks.
• Understanding of technical, engineering, or medical terminology, with the ability to reference literature.
• Technical skills in manufacturing or design related to regulatory affairs are advantageous.

Interested applicants, please send in your application by clicking "Quick 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.