Project Manager/Product Expert - Medical Devices - APAC

Project Manager/Product Expert – Medical Devices – APAC

Location: APAC, Home / Office based.

Type: Permanent.

Salary: Negotiable

Job Functions:

Access and review client’s medical device files for regulatory requirement mainly for European and US markets.

Utilize knowledge of regulatory requirements applying to manufacturers’ processes and products.

Audit manufacturers ensuring continued compliance to MDD, AIMD, IVD, etc.

Review product design, documenting any deficiencies, review engineering and manufacturing.

Audit experience to include and ISO 13485.

Create reports for clients utilizing analytical skills, technical knowledge and excellent written communication skills.

Analyze complex regulatory requirements and make sound determinations of the proper course of action.

Work with external consultants.

Requirements:

Minimum 4 year degree in either Engineering, Biomedical, Medicine, Pharmacy, (Micro) biology, Biotechnology, Clinical Physics or related discipline of medical devices.

Technical knowledge 5 – 7 years experience in Medical Device industry and Regulatory Affairs field.

MS degree in related field preferred but not required.

Knowledge of engineering and technical applications used in the development of medical devices.

Strong background in either design engineering or R & D

Global Regulatory Affairs background including CE Medical Device Directives.

Experience with one or more MDD, AIMD, IVD, Tissue Directives.

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