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: 
This role will advance Regulatory Affairs (RA) functions by planning and driving initiatives focused on continuous improvements and operational excellence of regulatory systems and processes, as well as creating and maintaining mechanisms for rapid tactical execution of regulatory tasks. With a strong focus on Regulatory Information Management and Analysis, playing a key role in aligning processes and facilitating the effective execution of regulatory related activities; helping to ensure the right level of cross-functional transparency and accountability through the regulatory process.  

Essential Duties and Responsibilities:

• Regulatory Intelligence and Product Launch
  • Support regulatory processes related to regulatory intelligence requirements gathering in APAC
  • Participate and provide support in cross-functional collaboration on new product and country launches
• Continuous Improvement and Process Alignment
  • Maintain regulatory operations processes, systems, and documentation within APAC
  • Support in regulatory process creation and updates including drafting of SOPs and Wis.
• Change Management
  • Anticipate regulatory or related obstacles and emerging issues throughout the product lifecycle, leveraging and developing a mechanism for regular review and associated actions
  • Supporting Corporate and Global change management initiatives and assisting with associated change management in APAC
• RIMS Administrator and Regional Support
  • Maintaining and upkeep of the Regulatory Information Management System (RIMS) and related processes within APAC to facilitate the centralisation of common documentation in support of global registration activities and processes

Education and Experience:

• Degree qualified preferably in a Science or Engineering discipline 
• This position requires 2-3 years of experience
• Training in technical operational aspects of Regulatory Affairs, 
• Previous experience with technology or regulatory platform implementation is highly advantageous

Knowledge and Skill Requirements/Specialised Courses and/or Training:

• Excellent knowledge of current regulatory requirements in US, EU, or other regions a plus
• Regulatory Affairs Certification (RAC) an added bonus
• Ability to work in fast paced environment and handle multiple tasks and requests
• Strong organisational and project management skills, with meticulous attention to detail
• Ability to navigate the regulated environment, working with established procedures and identifying gaps to establish processes and procedures as needed
• Able to work independently as well as part of a cross-functional team, with exceptional written and oral communication skills and the ability to successfully build effective working relationships
• Comprehension of technical, engineering or medical terminology, and/or ability to reference literature for understanding
• Ability to read and comprehend scientific literature to, collect data, establish facts, draw valid conclusions and produce scientifically-supported documentation

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.