Regulatory Affairs Specialist (Medical Devices/Drugs ) , Central , $5,000 URGENT!!
jobsDB Ref. JSG400003003182375
EA License No 08C2893
- Responsible to support business strategic launch activities towards Company’s compliance according to Health Products & Therapeutic Products Act in Singapore.
- Complete regulatory submissions, including but not limited to new product applications,clinical trial applications, change variation/notification, special authorization routes for new & currently registered products portfolio in Singapore & Brunei.
- Manage submissions requirements through the regulatory management database (RMD).
- Maintain drug and device registration files, technical files, resources, relevant legislation and projects for Singapore & Brunei.
- Provide input and support to AP Quality Regulatory Environment Management (APQREM) team & local business team to manage Regulatory Affairs budget , change orders for medical devices & drugs
- Provide updates & maintain database to APQREM on the registration status of devices & drugs.
- Create, maintain & update registration/customs clearance database, license information, quality certificates, safety data sheets for all local relevant departments (eg business, 3rd party logistics service provider & supply chain).
- Review the promotional material, co-ordinate the approval process within the organization in order to comply with the HSA medical device sales & advertisement promotion guidance
- Ensure that redressing activities are carried out in accordance to GMP requirements & work with 3rd party to ensure that all aspects of redressing are met to ensure adherence to HSA
- Responsible for reporting to HSA for adverse events, recalls & Field Safety Corrective Actions(FSCA) in relation to medical devices & drugs.
- Responsible for reporting to HSA for adverse drug reaction (ADR), adverse events (AE), Field
- Safety Corrective Actions (FSCAs) & recalls.
- Maintain & update all relevant SOPs & Site Master File (SMF) in relation to GDP & GDPMDS,HSA technical specifications.
- Responsible for maintaining Importer & wholesaler license for medical devices & drugs to
- ensure compliance to HSA GDP & GDPMDS technical specifications.Address & close of Corrective Action Preventive Actions (CAPA) for major non conformities (NC) upon completion of any GDPMDS certification body (CB) external audits or GDP HAS
- Candidate must possess at least a Degree in any field
Interested candidates who wish to apply for the advertised position, please email us an updated copy of your resume (Attn: BNC) or contact our office at +65 6709 3560 for a confidential discussion.
Job Code: BNC
EA License No.: 08C2893