RA Specialist

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

Responsible for product registration submission to and get product certificate and QSD certificate from TFDA.

Communicate local regulation and standard requirements to legal manufacture. 

Job Responsibilities and Essential Duties

• Assist QRC Manager to establish and implement registration strategy to achieve regulatory approval.
• Prepare pre-market submissions (including preparing registration files etc.) and obtain approval of premarket product registration timely.
• Acts as the regulatory partner to BA/PA RA.
• Interact with TFDA on registration requirements and monitor changes to requirements.
• Independently manages and monitors multiple complex and diverse short term and long-term
  projects without direct supervision. Interacts with manager as required by specific issues, milestones, or status changes.
• Coordinates with legal manufacture on local language master label and IFU.
• Monitors local regulatory and standards developments affecting Getinge product and feedback to relevant internal stakeholders.
• File and manage regulatory documentation including submission documentation, product licenses, and relevant communication records.
• Assist QRC manager to build local WIN on regulatory operations and focus on implementation.
• Provide necessary trainings to internal employees.
• Other matters assigned by QRC Manager.
• Accept any tasks or job-re-arrangement assigned by company based on business needs.

Minimum Requirements

Bachelor's degree or higher with a background in medical and health related disciplines.

At least 2 years of relevant work experience.

Required Knowledge, Skills and Abilities

Good internal/external communication skills, good interpersonal skills.

Ability to write and read in English and write in Chinese to achieve the key points and write clearly in words.

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.