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Regulatory Affairs Associate / Senior Associate, APFresenius Medical Care Asia-Pacific Ltd
  • Wan Chai
  • Salary provided
  • Posted on 14 Nov 2019
Regulatory Affairs Associate / Senior Associate, APFresenius Medical Care Asia-Pacific Ltd

Job Highlights

  • Market leader in medical device industry
  • Regional exposure
  • Min. 2 yrs experience

Job Description

Based in Hong Kong, at our Asia Pacific Headquarters and reporting to the Senior Regulatory Affairs Manager(Device), Asia Pacific, this position will be responsible for all aspects of regulatory activities for the region, including support of registration applications for assigned medical devices, labeling development / management and regulatory database maintenance.

Key Areas of Responsibilities:

  • Prepare, review & advise on documents for regulatory submissions for Asia Pacific countries
  • Ensure applications are in line with manufacturers’ and national requirements.
  • Tracking applications, make sure progress is made in accordance with commitments and timelines
  • Develop, maintain and provide regulatory guidance on labeling, to ensure the compliance with the regulation of local countries and the country of the manufacturer
  • Maintain databases for medical device licenses and Asia Pacific specific labeling
  • Compile status report for on-going applications
  • Provide regulatory input and strategies for product launch and design change
  • Provide support to tender applications
  • Undertake other ad hoc projects as assigned

Qualifications, Experience and Characteristics Required:

  • University graduate in Science or Medical related field
  • At least 2 years regulatory affairs experience with drugs and/or medical devices, with multinational companies preferably on a regional basis
  • Experience in labeling management is preferred
  • Detail oriented and able to work independently
  • A team player with good communication and interpersonal skills
  • Good command of written and spoken English and Chinese
  • Candidates with more relevant experience will be considered as Senior Associate

 

Please submit your CV with current and expected salary if you are interested.

(Data collected will be used for recruitment purposes only. Candidates should consider their applications unsuccessful if not invited for interview within six weeks.)

Additional Information

Career Level
Entry Level
Qualification
Degree
Years of Experience
2 years
Employment Type
Full Time, Permanent
Company Website

Company Overview

Fresenius Medical Care - the world's leading provider of products and services for people with chronic kidney failure in around 150 countries. We care for more than 320,000 patients in our global network of more than 3,700 dialysis clinics.

Creating a Future Worth Living. For Patients. Worldwide. Every Day.

We are listed on Frankfurt Stock Exchange and New York Stock Exchange and is included in DAX German market index since 1999.

Additional Company Information

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

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