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Regulatory Affairs Specialist, Asian Growth Market
jobsDB Ref. JSG400003002988143
EA License No 12C6254
Headquartered in the United States, our client is a leading designer and manufacturer of respiratory medical equipment. With more than 4000 employees worldwide, they are aggressively expanding their operations in Singapore and Asia Pacific.
Regulatory Specialist, Asia Growth Markets
- Manage preparation (developing submission content, management of document legalization, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan.
- When required, ensure timely, professional and proactive communications with internal and external customers on issues, challenges and updates relating to product submission, renewal and change.
- Control and maintain regulatory records, including, but not limited to: submission documentation, tracking of part number approval per country, establishment registrations, import for export, etc.
- Support external customers such as distributors, agencies and product test house on regulatory manners.
- Monitor and communicate new and changing medical device law, guidance regulations in a timely manner
- Provide appropriate inputs to assist in defining regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical and non-medical software products.
- Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, especially within Growth Markets, Asia country specific Medical Act and ASEAN MDD regulations and policies applying to medical devices.
- Identify, develop, implement and document process improvements to drive efficiency within the organization.
- Other duties relating to regulatory affairs may be assigned as required.
- Bachelor’s Degree in Biomedical engineering or equivalent with minimum three years working in regulatory affairs within medical device industry
- Experience with medical device submissions in S.E.A region
- Experience working/interacting with regulatory authorities
You can also contact Vincent Low for a confidential discussion at 6749 4236.
EA Personnel Registration No: R1324700