Regulatory Affairs Manager
Salary Market aligned
Consultant Kevin Setiawan
Date posted 13 June 20192019-06-13 2019-08-12 medical-and-nursing Jakarta ID IDR 30000000 35000000 35000000 MONTH Robert Walters https://www.robertwalters.co.id https://www.robertwalters.co.id/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
A Global Medical Devices company is looking to hire a Regulatory Affairs Manager. The candidate will be responsible for coordinating regulatory affairs processes for Medical Device in Indonesia. To act as internal interface to local, regional and global organisation to coordinate Quality Management.
About this Regulatory Affairs Manager role:
As a Regulatory Affairs Manager, this individual will communicate regulatory initiatives or changes in the applicable medical device laws with company personnel, customers, subcontractors, regulatory agency representatives, and third party organisations.
• Prepare regulatory submissions
• Interface with the regulators on assigned projects
• Respond to regulator requests for additional information
• Keep abreast of changes to the Asia regulatory requirements and International Standards related to our products and processes
• Review documentation for assigned projects and proposed individual changes to insure compliance with the Company's quality system procedures and determining whether regulatory submissions are required
• Identify, investigate and close out corrective and preventive actions
• Participate on the review board for the review and approval of promotional advertising and literature
• Oversee maintenance of regulatory files to ensure the Company's compliance with regulatory requirements
• Bachelor's degree in Pharmacy, Bioengineering, or Life Science preferred
• Certified Internal Auditor is a plus
• Familiar with Indonesia and ASEAN regulatory requirements and submissions
• Skill in the conduct of research on the Worldwide Web for regulations, guidelines, standards, medical device information, etc.
• Familiarity with ASEAN CSDT knowledge is a plus
• Familiarity with electronic submission is a plus
If you are driven, determined, and want to take further step in your career, this is the role for you. Attractive remuneration package as well as excellent career progression awaits the right person in this exciting Regulatory Affairs Manager role.
Apply today or call me to discuss this new job opportunity.