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™.
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:
- 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
Interested applicants are to apply online with us!
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.
