Job Title

Job Description

• Supporting regulatory planning for new product introductions and product changes, and assist in maintaining, regulatory compliance.
  
• Product submissions, global registrations and communication with authorities
  
• Managing compliance to global regulations, standards and guidelines Guide R&D, clinical and marketing teams regarding regulatory related considerations
  
• Regulatory support for internal audits, external audits and inspections.
  
• Recommends changes for labelling to ensure regulatory compliance.
  
• Monitors and improves tracking/control systems.
  
• Keeps abreast of regulatory procedures and changes.
  
• Represent Regulatory Affairs as team member of product development projects.
  
• Monitor and provide information pertaining to impact of changes in the regulatory environment
  
• Review regulatory procedures and update as necessary.
  
• Review SW release documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments
  

• Academic degree in computer science, biological sciences, engineering or equivalent
  
• Experience in regulatory roles
  
• Fluent English
  
• Good analytical skills and writing skills
  
• Good understanding of the Quality System Regulation (ISO 13485, MDR, 21 CFR Parts 803, 806 and 820) is a plus
  
• Ability to interact and communicate in English, including demonstrable writing, speaking, and comprehension skills; ability to communicate across levels of the organization