Regulatory Affairs Administrator

Job Title
Regulatory Affairs Administrator

Job Description

As Regulatory Affairs Specialist you will support product regulatory plans and product registrations, participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements and standards

Your role:

• 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
  
  

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.