• Location: Raffles Place
• Working hours: 08:30 to 17:30 (Monday to Friday)
• Salary: Up to $6,000 (depending on experience)
Regulatory Affairs Specialist/Assistant Manager (Compliance, Medical Devices)
Our client, a medical device manufacturing company, is looking for a Regulatory Affairs Specialist. The successful candidate should have experience with products in Class C or D medical devices that are of high risk.
Key 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 documentation 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
Post-marketing activities
- Coordination with the relevant people (Sales/Marketing, GHQ-QA) and report to authorities if necessary
Collection of Regulatory information
- 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 promptly
Team Management (depending on experience)
- Managing team, planning and goal setting for team
- Work allocation, monitoring, and review of team performance
- Provide guiding assistance to the members
- Supporting team members with training and development activities
Budget control
- Develop budgets and perform budget control if required
- Make proposals to reduce cost
Fostering subordinate (depending on experience)
- Promote activities for subordinates’ skill-up
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 3-5 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
- Fluency in Japanese to liaise with Japanese-speaking counterparts in Japan will be a plus but not a must
- Infrequent business trips may be required to visit countries in charge to attend seminars
Interested applicants, please send your resume to Charlene (R22105303) at [email protected] with the email subject header "Job Application for 18855, Regulatory Affairs Specialist/Assistant Manager".
We regret that only shortlisted candidates will be notified. Other applications will be updated in 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
(Lau Rui Lin, Charlene, EA Registration No: R22105303)
