Regulatory Affairs Specialist, SEA

Arthrex; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A global medical device company in Singapore is seeking a Regulatory Affairs Specialist for the SEA market. The role involves managing regulatory submissions and ensuring compliance with local regulations. Responsibilities include preparing submission dossiers, communicating with regulators, and staying updated with regulatory changes. Candidates should have a degree in Engineering or Science and 3-4 years of regulatory affairs experience in the medical device industry. This position supports a dynamic and fast-paced work environment.

Qualifications

• Minimum 3-4 years direct regulatory affairs experience within a medical device company.
• Comprehension of technical, engineering or medical terminology.
• Knowledge of global regulations is advantageous.

Responsibilities

• Responsible for daily operations of regulatory affairs and compliance.
• Prepare and compile submission dossiers for reportable changes.
• Communicate with regulators on submission projects.

Skills

Strong working knowledge of SEA medical device regulations

Excellent interpersonal skills

Ability to work independently and in teams

Ability to manage multiple tasks

Education

Degree in Engineering or Science discipline

Tools

MS Office (Word, Excel, PowerPoint, Outlook)

PC and research tools

Job description

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 Changes (RA Compliance and Document Control)
  • Performing analysis 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
• 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
• 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

Incidental Duties

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience

• Degree qualified preferably in an Engineering or Science discipline
• Minimum 3-4 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

Machine, Tools, and/or Equipment Skills

• PC, database, research tools, internet research tools
• MS Office skills (Word, Excel, PowerPoint, Outlook)

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required.

Physical Demands

Good physical and mental health. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to be mobile and must be able to lift and/or move up to 5 kilos.

Vision Requirements

Meets vision requirements to use personal computer and read documents.

Work Environment

Regularly work at the Buona Vista office or visit to vendor/supplier locations. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Internal and External Relations

The position maintains ongoing relationships with internal stakeholders, Arthrex customers, and regional/global teams in order to support/perform duties in this position. It is required the ability to obtain cooperation and convey accurate information in a timely manner.

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.

Title

Regulatory Affairs Specialist SEA

Location

Singapore, 05, SG, 138567