Regulatory Affairs Specialist / Senior Specialist (Medical Devices) - TK

Our client, a medical device manufacturing company, is looking for a Regulatory Affairs Specialist / Senior Specialist . The successful candidate should have experience with products in Class C or D medical devices that are of high risk.

Job Responsibilities:

Regulatory application, Compliance

• Responding to company policy and company requirements, propose strategic regulatory application and carry it out.

• Assess regulatory requirements and develop regulatory strategies for the qualifications of new products in the company's territories.

• Compile technical files, test reports and documentations necessary for regulatory submissions.

• Maintain up-to-date documentation, archival regulatory submissions, and related documents according to the company's documentation policies and procedures.

• Maintenance of GDPMDS and ensuring staff's compliance with SOPs.

• Coordination with internal/external people for application/ query response document procurement.

• Coordination with the other govt. authorities as and when required and instructed by upper-rank personnel.

• Collect and compile regulatory information/updates and report to upper-rank personnel and people involved.

Schedule management

• Manage schedules for regulatory submissions and make adjustments with an understanding of the importance of company policy and company requirements.

• Regarding schedule change, report upper-rank personnel and people involved in a timely manner.

Post-marketing activities

• Coordination with the relevant people (Sales/Marketing, GHQ-QA) and report to authorities if necessary.

Industrial activity

• Participate industrial activities and negotiate with authorities.

Others

• Follow your supervisor's instructions and other ad-hoc duties as assigned.

Job Requirements:

• Minimum 3 years of Regulatory Affairs experience for medical devices of at least Class C risk.

• Good communication skills to liaise with internal and external parties.

• Eyes for details to read and check the related documents such as practical law.

• Basic level in Japanese language to liaise with Japanese-speaking counterparts in Japan will be a plus but not a must

Interested applicants, please send your resume to Tiffany (R1104633) with email subject header Job Application for Regulatory Affairs Specialist (Class C or Class D Medical Devices) - TK for immediate processing.

We regret that only shortlisted candidates will be notified. Other applications will be updated to our database for future job opportunities.

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Thank you for your kind understanding and co-operation.

Pasona Singapore Pte Ltd

EA License No:90C4069

R1104633

Koh Jia Wen