(Senior) RA Specialist

Getinge; Hong Kong; On-site; HKD 300,000 - 520,000; Full time

Job summary

Getinge in Hong Kong seeks a Regulatory Affairs professional to lead product registration and lifecycle maintenance for HK and Macao markets. You will collaborate with global and local teams to ensure regulatory compliance and timely approvals.

The role requires strong knowledge of medical device regulations in HK/Macoes, capable English and Cantonese communication, and the ability to manage submissions, record-keeping, and audit support with minimal supervision.

Qualifications

• Develop and implement regulatory strategies for HK/Macao projects.
• Prepare and submit regulatory applications to local authorities.
• Coordinate product changes and lifecycle maintenance.
• Maintain regulatory records and submission dossiers.
• Support audits and QRC activities.
• Assist line management with other regulatory tasks.

Responsibilities

• Regulatory Affairs (HK/Macao focus) and lifecycle management.
• Collaborate with global and local teams on regulatory strategies.
• Prepare, coordinate and submit regulatory filings to health authorities.
• Maintain submission dossiers and regulatory communications.
• Support internal and external audits and QMS activities.

Skills

Regulatory submissions

Regulatory affairs

QMS knowledge

Communication skills

Bilingual English/Chinese

Education

Bachelor’s degree in Biomedical Engineering / related field

Job description

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.

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

This role is responsible for planning and implementing product registration and lifecycle maintenance activities in the Hong Kong and Macao markets, as well as other tasks assigned by line manager.

Job Responsibilities And Essential Duties

• Regulatory Affairs (75%)
• Collaborate closely with global and local teams to develop and implement regulatory strategies for assigned projects.
• Prepare, coordinate, and submit regulatory applications to the local health authorities to ensure timely approvals.Review product change assessment requests and take actions accordingly to ensure regulatory compliance and secure business continuity.
• Provide regular updates to internal stakeholders on product registration progress and regulatory trends affecting Getinge products.
• Maintain and organize regulatory records, including submission dossiers, product licenses, and related communications.
• Others (25%)
• Support SSU QRC activities, such as internal/external audits.
• Other responsibilities as directed by line management.

Minimum Requirements

• Bachelor’s degree or above in Biomedical Engineering, Medical Sciences, Biotechnology, or a related science/engineering field.
• 2-4 years’ experience in product registration or QMS in the medical device Industry. Work experience in MNC is highly preferred.
• Proven track record in regulatory submissions in Hong Kong, including new listings and product changes.
• Solid understanding of medical device regulations and applicable requirements in Hong Kong and Macao markets.
• Good internal/external communication skills, good interpersonal skills.
• Basic understanding / willingness to learn medical device registration processes, QMS requirements to support compliance with ISO 13485 / ISO 9001.
• Independent with strong self-initiative
• Good command of written and spoken English and Chinese; Cantonese preferred

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.