ORTHOPEADIC MEDICAL DEVICE PRODUCT EXPERT - APAC REGION

ORTHOPAEDIC PRODUCT EXPERT – MEDICAL DEVICES – APAC

Industry: Implants / Orthopaedic / Soft Tissue/ Tissue Engineering / Dental.

Job Title: Scheme Manager – Technical Specialist – Medical Device Expert – Certification Manager – Project Manager – Design Control Manager – R&D Manager – Design Engineer.

Location: ANYWHERE Home/Office Based, APAC.

Salary: Negotiable

Bonus: 10-15%.

Training: Yes (Full).

Type: Permanent.

Purpose:

Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise.

Deliver technical reviews, scheme management and QMS assessment in support of the CE marking schemes.

Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of competence to Healthcare personnel

Provide “Technical Sales/Networking” support to the commercial team.

Responsibilities & Accountabilities:

Deliver Medical Device CE Marking technical review, scheme management and ISO 13485 QMS assessment services as a fully integrated member of the O&D Team.

Work with O&D team and other team leaders as required to provide QMS assessment within area of expertise.

Provide advice and support to product specialists and scheme managers on certifications in area of expertise that may have a regulatory challenge.

The jobholder will be a member of the O&D Team reporting to the Team Manager and work as a colleague with other members of the Medical Devices Business Stream.

Knowledge / Skills / Abilities:

• BSc degree or PhD in a discipline relevant to medical device manufacture and use, or equivalent qualification


• Thorough knowledge of the design and development of medical devices in area of experience, including the principles of design control, risk management and performance or clinical evaluation


• Experience in one or more of the following disciplines: Orthopaedic implants (specifically spinal devices); Dental implants; General orthopaedic & non-active devices


• Thorough knowledge of Medical Device regulation


• Concepts and intent of Product Certification and service orientation

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