RA Specialist

Link HRM B.V.

Headhunting
Our client company is looking for a RA Specialist.

Company description: 
Focus on serving the ophthalmology industry in China for the past two decades; The client company has developed into an ecosystem that consists of research and development, manufacturing, sales and distributions, educational training, product technical and clinical support, and medical information system development.
With persistence and dedication, the client company has built a trustworthy brand name for its advanced products and reliable services in the ophthalmic device field. It carries products in vitreoretinal, refractive, glaucoma, cataract, diagnosis and etc. The client company is determined to continually broaden its ophthalmic device horizon with innovation.
Over the years, the client company has built a large sales team with distribution channels throughout China. The client company collaborates with over 10,000 hospitals for providing products and services.

Job responsibilities:
  1. Lead the initial product registration for the manufacturing site in China including coordination and creation of all required submission documents in time to NMPA and Notified Body;
  2. Maintain the registration license of the products in manufacturing site in China;
  3. Sep up the databased of global regulations and standards which are applied for China site, and lead the gap analysis for new/updated regulations and standards;
  4. Contribute to the Change Control process by performing regulatory impact evaluation of changes;
  5. Review of registration relevant documents for regulatory and standards compliance;
  6. Provide documents related to manufacturing site to support international product registrations;
  7. Labeling review according to global regulations;
  8. representation of RA during projects to assure early consideration of Chinese and international regulatory requirements;
  9. Review governmental rulings to determine changes in legal requirements and possible effects, manage and implement changes as required; update and optimize RA SOPs or WI accordingly;
  10. Local RA budget planning and overview;
  11. Perform other management functions as authorized by superior.

Job requirements:
  1. Bachelor degree or above
  2. +5 years experience in China registration and CE registration for medical devices of high risk classes (class III);
  3. +2 years Registration of sterile medical device experience is preferred;
  4. Registration experience of implantable medical device experience is preferred;
  5. Proficiency in Microsoft Office software; 
  6. Speak fluent English, as well as profecient in and write in English;
  7. In depth knowledge of Chinese regulation especially for clinical affairs and registration;
  8. Good knowledge of European and FDA regulations, International standards and guidance documents related to manufacturing of medical devices;
  9. Good understanding of product life-cycle process including R&D, design transfer, production, post market surveillance;
  10. Understanding of authorities mind set and expectations;
  11. Ability to write easy to understand registration documents, rationales; well designed and organized, professionally presented.

Work location:
Spankeren, Netherlands 
This position requires to relocate to Shenzhen (China) from 2023.


Opportunity to get working visa sponsorship for candidates (KM)

Maximum size 10MB

Maximum size 10MB

We will keep your CV and contact information in our Talent Pool. We will contact you if there is suitable position for you.

Please wait...
Headhunting
Our client company is looking for a RA Specialist.

Company description: 
Focus on serving the ophthalmology industry in China for the past two decades; The client company has developed into an ecosystem that consists of research and development, manufacturing, sales and distributions, educational training, product technical and clinical support, and medical information system development.
With persistence and dedication, the client company has built a trustworthy brand name for its advanced products and reliable services in the ophthalmic device field. It carries products in vitreoretinal, refractive, glaucoma, cataract, diagnosis and etc. The client company is determined to continually broaden its ophthalmic device horizon with innovation.
Over the years, the client company has built a large sales team with distribution channels throughout China. The client company collaborates with over 10,000 hospitals for providing products and services.

Job responsibilities:
  1. Lead the initial product registration for the manufacturing site in China including coordination and creation of all required submission documents in time to NMPA and Notified Body;
  2. Maintain the registration license of the products in manufacturing site in China;
  3. Sep up the databased of global regulations and standards which are applied for China site, and lead the gap analysis for new/updated regulations and standards;
  4. Contribute to the Change Control process by performing regulatory impact evaluation of changes;
  5. Review of registration relevant documents for regulatory and standards compliance;
  6. Provide documents related to manufacturing site to support international product registrations;
  7. Labeling review according to global regulations;
  8. representation of RA during projects to assure early consideration of Chinese and international regulatory requirements;
  9. Review governmental rulings to determine changes in legal requirements and possible effects, manage and implement changes as required; update and optimize RA SOPs or WI accordingly;
  10. Local RA budget planning and overview;
  11. Perform other management functions as authorized by superior.

Job requirements:
  1. Bachelor degree or above
  2. +5 years experience in China registration and CE registration for medical devices of high risk classes (class III);
  3. +2 years Registration of sterile medical device experience is preferred;
  4. Registration experience of implantable medical device experience is preferred;
  5. Proficiency in Microsoft Office software; 
  6. Speak fluent English, as well as profecient in and write in English;
  7. In depth knowledge of Chinese regulation especially for clinical affairs and registration;
  8. Good knowledge of European and FDA regulations, International standards and guidance documents related to manufacturing of medical devices;
  9. Good understanding of product life-cycle process including R&D, design transfer, production, post market surveillance;
  10. Understanding of authorities mind set and expectations;
  11. Ability to write easy to understand registration documents, rationales; well designed and organized, professionally presented.

Work location:
Spankeren, Netherlands 
This position requires to relocate to Shenzhen (China) from 2023.


Opportunity to get working visa sponsorship for candidates (KM)

Maximum size 10MB

Maximum size 10MB

We will keep your CV and contact information in our Talent Pool. We will contact you if there is suitable position for you.

Please wait...