Regulatory Affairs Manager
1 week ago
Duration : 1 year contract extendable
Working Hours :
Monday to Friday 9am to 6pm
Working location :
Bugis
Responsibilities:
- Coordinate and manage all related RA activities and APAC regional projects
- Responsible for premarket submission and postmarket surveillance management of IVD medical device products for ARDx SG Affiliate.
- Support and develop regulatory submission plan for the region in collaboration with project team, manufacturing sites, supply chain, marketing and country manager
- Work closely with relevant manufacturing sites and other functions to obtain all the necessary documents to support product registration, renewal or amendment to existing product certificates
- Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders.
- Responsible for review of promotional material for Singapore.
- Track regulatory milestones in internal Regulatory database;
- Report submission status via defined Key Performance Indicators
- Lead and support APAC region team on assigned projects (e.g. change notification, rebranding, site transfer, NPIs).
- Track and maintain status of APAC regional projects by working closely with country Regulatory teams.
- Share project status to identified stakeholders on a regular basis with appropriate scorecards. Ensure timely execution of regulatory strategies as per plan, identify risk at an early stage and develop mitigation plans as needed.
Requirements:
- Bachelor's Degree or higher in Pharmaceutical and Life Sciences, Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
- A minimum of 5 years' experience in Regulatory Affairs in Medical Devices, ideally in IVDs
- Demonstrable working knowledge of the medical diagnostics industry, including Software as a Medical Device (SaMD).
- Strong knowledge of and demonstrated experience in IVD Medical devices registration for Singapore.
- Demonstrated capacity in project management,
- Able to navigate in a cross functional environment
- Knowledge of the APAC regulatory environment, including SaMD US FDA and regional digital health regulations and requirements, legislation, industry standards and guidance
- Excellent written and oral communication skills Strong interpersonal and communication skills.
- Salary : S$ to S$6,500.
PERSOLKELLY Singapore Pte Ltd - RCB No E - EA License No. 01C4394
**R Teresa Chan Poh Pin)
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