Regulatory Compliance Engineer

Based within this diverse and successful team, you will be working in a post-market data surveillance team to play a pivotal role in regulatory compliance and drive continuous improvement.

THE ROLE:

• Load, analyse and review post-market data to determine whether regulatory reporting or further action is required.

• Seek product surveillance information as necessary to ensure all relevant information is recorded, assessed, and processed in a timely manner.
• Develop vigilance reports and responses to regulatory bodies to ensure regulatory compliance and limit regulatory risk. Utilise metrics to ensure these are handled in a timely manner.
• Assist with post-market surveillance training to support coaching, mentoring, and continuous development.
• Assist with post-market projects, including Design Intent, Field Actions, and Health Hazard Evaluations such that they are effective and completed on time.
• Draft customer responses in a timely manner that ensure customer satisfaction.

ABOUT YOU:

• Tertiary qualification (in engineering, biological science, medicine, or business)
• Impeccable analytical skills and attention to detail
• Risk management, an understanding of business and customer risk (minimising risk to business)
• Work in a similar role (come from an analytical background within the healthcare industry or QA environment)
• Effective communication skills (phone and email)

If you are interested in applying or knowing more about this role, please apply now or email hconole@welovesalt.com