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Regulatory Affairs Manager

2 weeks ago

Central Singapore PERSOLKELLY Full time

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

Duration : 1 year contract extendable

Working Hours : Monday to Friday 9am to 6pm

Working location : Bugis

**Responsibilities**:

- Co-ordinate and manage all related RA activities and APAC regional projects
- Responsible for pre-market submission and post-market 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$5000.00 to S$6,500.00 with completion bonus

**PERSOLKELLY Singapore Pte Ltd - RCB No. 200007268E - EA License No. 01C4394**
**R1107631 (Teresa Chan Poh Pin)