Medical Device Regulatory Lead: Registration and Compliance

CorDx; Singapore; On-site; SGD 100,000 - 125,000; Full time

Job summary

A medical device company in Singapore is seeking an experienced professional to manage product registration processes for various medical devices. The ideal candidate will have a Bachelor's degree in Life Sciences or Pharmacy, along with expertise in regulatory laws and ISO13485 quality management. Responsibilities include liaising with regulatory agencies, preparing registration dossiers, and overseeing project management. The position demands strong communication skills, meticulous attention to detail, and the ability to thrive under pressure.

Qualifications

• Complete registration experience of Class B, C and D medical devices.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay.
• Meticulous and able to handle stress and tight schedules.

Responsibilities

• Prepare registration dossier and manage communication with CRO.
• Interface communication with regulatory agencies.
• Collaborate with cross-functional teams to meet project goals.

Skills

Expert in medical device product registration laws

Good presentation skills

Project management

Strong communication skills

Results driven

Education

Bachelor's degree in Life Sciences, Pharmacy, or related field

Tools

ISO13485 quality management system

Job description

A medical device company in Singapore is seeking an experienced professional to manage product registration processes for various medical devices. The ideal candidate will have a Bachelor's degree in Life Sciences or Pharmacy, along with expertise in regulatory laws and ISO13485 quality management. Responsibilities include liaising with regulatory agencies, preparing registration dossiers, and overseeing project management. The position demands strong communication skills, meticulous attention to detail, and the ability to thrive under pressure.