Associate Regulatory Affairs Specialist SEA

Arthrex; Singapore; Vor Ort; SGD 60.000 - 90.000; Vollzeit

Zusammenfassung

Arthrex, Inc. is seeking a Regulatory Affairs person to manage SEA submissions and ensure regulatory compliance across SEA markets. The role involves coordinating with regulators, planning for regional changes, and supporting APAC projects as needed.

The candidate should have a science/engineering degree and 1–2 years of RA experience in medical devices, with strong communication and multitasking abilities. Knowledge of labeling and post-market activities is a plus.

Qualifikationen

• Minimum 1–2 years direct RA experience in medical devices.
• Strong knowledge of SEA medical device regulations.
• Excellent communication and stakeholder management.
• Ability to manage multiple tasks in a fast-paced environment.

Aufgaben

• Manage RA submissions and applications for SEA markets.
• Communicate with regulators on submission projects.
• Prioritize and organize multiple projects with competing priorities.
• Support regulatory changes planning for SEA; assist APAC projects.
• Review labeling and DFU translations as needed.
• Maintain product registrations and listings databases.
• Participate in post-market surveillance activities and audits.

Kenntnisse

Regulatory submissions

Regulatory communication

Project prioritization

SEA regulatory knowledge

Stakeholder collaboration

Ausbildung

Science or Engineering degree

Jobbeschreibung

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
• 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
• Minimum 1-2 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