MISSION:

You will independently perform and manage regulatory activities within a highly regulated, fast-paced industry to ensure that Company objectives are achieved in compliance with regulatory requirements.

You master the relevant local regulations in countries where IBA applies for product registration and clinical trials (esp. China and other markets like EU and US), alternatively, you are able to select and collaborate with appropriate local representatives to obtain product registration and/or clinical trials clearance in countries where IBA cannot apply directly (e.g. Japan, Brazil).

As Regulatory Affairs Expert, you develop and adapt the Regulatory processes and associated procedures & tools according to applicable regulations. You are able to train the IBA staff and address any auditors questions on regulatory processes.

CHALLENGES WE TRUST YOU WITH:

• Manage complex regulatory projects:
  
  
  
  1. Ensure consolidated technical files meet the regulatory requirements and are kept up to date;
  
  
  2. Compile and submit complex regulatory submissions to regulatory authorities and notified bodies;
  
  
  3. Coordinate the preparation and the delivery of reviewing responses to regulatory authorities and notified bodies. Maintain registration information (license numbers, certification declaration, etc) and obtain re-registration approvals in advance of license/certification expirations.
  
  
  
  


• Identify laws, regulations, standards and guidance applicable to the organization in the target markets as defined by the management and according to the product specificities;


• Ensure regulatory compliance with applicable standards, directives and regulations;


• Meet with Regulatory Agencies/Competent Authorities to organize pre-survey deliverables and pre-survey submission strategy. Identify potential risks in submissions and anticipated regulatory responses through scenario planning;


• Communicate Regulatory requirements throughout the organization as appropriate and train IBA staff to regulatory processes as necessary;


• Develop and adapt the Regulatory processes and associated procedures & tools according to applicable regulations and IBA business expansion;


• Explain the regulatory processes during internal and external audits/inspections;


• Review and approve marketing and promotional materials and other types of external communications for compliance with regulatory requirements.

WHAT WE VALUE:

You have:

• University Degree;


• A minimum of 5 years of experience in medical device environment and regulatory affairs;


• Proven Medical Device registration in China is a plus;


• ISO13485 experience;


• High level computer literacy; including MS Office, SharePoint, Flowcharting software, Acrobat, etc;


• Adaptable and willing to take on multiple new tasks and responsibilities;


• Process oriented, logical, analytical, meticulous, highly organized and able to analyze data & implement solutions;


• Excellent high level oral & written communications skills enabling incumbent to act as a facilitator and / or educator with strong leadership skills;


• Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time;


• Willingness to travel;


• Fluent in English and good writing skills.