PRODUCT SPECIALIST - MEDICAL DEVICES EXPERT - CHINA (25529603)

PRODUCT SPECIALIST – MEDICAL DEVICES EXPERT – CHINA

Job Title: EU Notified Body Medical Device Product Specialist China.

Primary Report: Technology Team Leader.

Secondary Report: Local manager.

Location: Shanghai/Shenzhen, China.

Type: Permanent Employment.

Purpose of Position:

• Conduct Technical Reviews for medical device CE conformity assessment certification


• Manage a portfolio of medical device CE certification schemes


• Deliver ISO13485 audits


• Deliver medical device training courses


• Lead medical device system audit and build up technical competence


• Act as “Technical Sales/Networking focal point” in order to support business development.

Key Responsibilities & Accountabilities:

• Carry out EU medical device Technical File or Design Dossier Review and Scheme management for to meet CE conformity requirements of EU Medical Device Directives.


• Deliver ISO 13485 audit services and training courses.


• Support Medical Devices Lead Asia Pac in the formulation of local strategic plan.


• Act as technical regulatory sales support function to explore business opportunity through client visits and contact.


• Help marketing to prepare product manual or technical material upon request.


• Support resource development plan and raise the level of capability of current delivery team with Medical Devices Lead Asia Pac and Global MD Team.

Qualifications – Knowledge/skills/abilities:

• BSc degree in discipline relevant to Medical Device manufacture, or equivalent qualification


• Successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, natural science or engineering


• Four years professional experience in the field of healthcare products or related sectors (e.g. industry, audit, healthcare, research experience), with at least two years of experience in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.


• At least three years in the medical device sector in a role relevant to the design and development of either non-active medical devices, (such as orthopaedic, vascular, wound-care, IVD or ophthalmic devices) or active medical devices, as required by EU MDD.


• Appropriate knowledge of general safety, risk management and performance requirements laid down as well as related delegated and/or implementing acts, harmonised standards, CTS and guidance documents.


• Appropriate knowledge and experience of the conformity assessment procedures.


• Efficiency and results orientation.


• A good team player.


• Broad technical understanding of client industry and its products.


• Strong social and communicative skills in interaction with customers.


• Proficient written and spoken English and Mandarin is compulsory and Cantonese preferred.

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