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Regulatory Affairs specialist (Asia Pacific) *MedicalHeadsearch21 Consultancy Ltd
Regulatory Affairs specialist (Asia Pacific) *MedicalHeadsearch21 Consultancy Ltd

Job Highlights

  • Solid exp in APAC regulations for medical device
  • products with software, elect-components, etc
  • Documentation + Audit experience needed

Job Description

Our client is large-scale company, developing advance technologies for medical use. They are now looking for high caliber candidate to join the team.

 

Responsibilities:

  • Responsible for regulatory applications for the product market approvals in Asia Pacific.
  • Handling pre-market regulatory issues for the products; and post-market activities afterwards.
  • Ensure Asia Pacific Technical Files of products complies with the local regulatory and the Company's Quality Management System of the Asia Pacific regions.
  • Responsible for regulatory issues on new product introduction and engineering design control teams.
  • Ensure clinical research and clinical evaluation are performed in accordance with necessary regulatory requirements.
  • Perform internal and external audits.
  • Gather and prepare materials to enable Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc.
  • Organize materials and reports for clients and agencies.
  • Prepare different reports and documentation for clients, governmental regulatory agencies, etc.
  • Support Post Market Surveillance activities i.e. Complaint Investigations, FSCA, MDR, etc.

Requirements:

  • Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry
  • Solid working knowledge of the Asia Pacific regulations and standards applicable to medical device market clearance.
  • Experience in handling medical device in Asia Pacific Region. (especially products containing software and electro / mechanical components)
  • Proficiency in working through third parties to obtain market clearance in Asia Pacific countries.
  • Good command in Cantonese, English and Mandarin; especially in English.

 

Interested parties, please click the “apply now” or send your updated resume with current and expected salary in MS word format to cv @headsearch21.com .

Contact:
Ms. Nicole Yuen
Tel: 3188 3745

All information collected will be treated in strict confidence and be used for recruitment purpose only.
Company Web-Site: www.headsearch21.com
Hotline: (852) 3188 3586

 

Additional Information

Career Level
Not Specified
Qualification
Not Specified
Years of Experience
Not Specified
Employment Type
Full Time, Permanent

Company Overview

As a leading professional recruitment consultancy specialized in recruiting permanent and temporary positions, executive search and outsourcing services, our mission is to present the best talents to our clients, including Fortune 500 and multinational companies, HK listed organizations, small & medium sized enterprises, and help job seekers to find their dream job covering following sectors:

  • Accounting & Finance
  • Engineering
  • Human Resources & Administration
  • Information Technology
  • Logistics & Supply Chain
  • Merchandising & Manufacturing
  • Property & Construction
  • Retail Operation
  • Sales & Marketing

Additional Company Information

Benefits & Others
Five-day work week, Life insurance, Medical insurance, Performance bonus

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