Senior Regulatory Affair Engineer

Job Title

Job Description

In this role, you have the opportunity to

• Catch up for all the whole world new regulation and standard for defibrillator and related accessories.
• Provide regulatory guidance to the cross functional team.
• Lead regulatory strategy on the assigned projects.
• Work with the global team together.

You are responsible for

• Mainly responsible for standard Revie Board for the EC PRO SZ Team for ALS defibrillator and related accessories. Make sure that all the applied standard and regulation has been recognized and implemented on time.
• Advise Cross function team on regulatory strategy for specific product /solutions design, Issue impact assessment, post market risk assessment, labeling review, CAPA and any other request if needed.
• Responsible for regulatory planning for new product introductions and product changes for the whole world. Do the registration for the whole world, especially for the NMPA/EUMDR/510(k)/PMA.
• Identify potential regulatory approvals risks based on regulations change, country specific requirement or other unique characteristics of the project.
• Collaborate with worldwide colleagues regarding license renewals and updates.
• Support QMS audit, maintain regulatory files and tracking databases as required.
• Do regulatory training and draft working instruction for cross function team if needed.

You are a part of

• Professional Regulatory Team, with around 20+ team peers globally.

To succeed in this role, you should have the following skills and experience

• At least Bachelor degree of Biomedical Engineering, Pharmaceutical Engineering or Engineering related.
• Minimum 5 years’ experience in active medical device industry for Regulatory affair or testing.
• Be familiar with MDR, FDA and NMPA requirements (Class III active device experiences would be perfect).
• Be familiar with active medical device standard will be plus.  Testing experience would be perfect.
• English oral and written communication skills
• High efficiency on problem shoveling.
• Good player of multitask handling.
• Willing to communicate and cooperate with cross function team members.