Job Description

Job Summary:

• Coordinate and manage all related RA activities for the portfolio in Singapore
• Act as a RA Project Manager for APAC regional projects

Job Scope:

• Responsible for pre-market submission and post-market surveillance management of IVD medical device products for 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

APAC Regulatory Project Lead

• 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.

General

• Represents RA and/or APAC at relevant meetings
• Support strategic Quality and Regulatory Affairs Goals and objectives.

Job Requirement:

• BSc or equivalent, 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).
• Knowledge of and demonstrated experience in IVD Medical devices registration for Singapore
• Project management and 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
• Written and oral communication skills and attention to detail
• Interpersonal skills, highest levels of integrity and diplomacy.
• Capacity to maintain the highest levels of confidentiality. internally and externally

Additional Information:

• Salary - Open for discussion
• Contract duration: 12-month contract, renewable
• Commencement Date: Immediate
• Working days and hours: Mon to Friday, 9am to 6pm
• Location: Bugis, DUO Tower

Lyn, Yee Chen Fu EA License No. 02C3423 Personnel Registration No. R1110796

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