East Jobs Project Manager (regulatory Affairs ) 1 Year Contract Extendable Position at PERSOLKELLY Singapore Pte Ltd (Formerly Kelly Services Singapore Pte Ltd)

Job Info

Company	PERSOLKELLY Singapore Pte Ltd (Formerly Kelly Services Singapore Pte Ltd)
Position	Project Manager (regulatory Affairs ) 1 Year Contract Extendable
Region	East
Career Level	Senior Executive
Work Experience	5 years
Qualification	Bachelor's Degree, Doctorate (PhD), Master's Degree, Post Graduate Diploma, Professional Degree
Type of Work	Full-Time
Minimum Salary	SGD 5.000
Maximum Salary	SGD 6.500

• 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 skills

Location : Beach Road

Interested candidate please click “APPLY” to begin your job search journey and submit your CV directly through the official PERSOLKELLY job application platform – GO Mobile.

We regret to inform that only shortlisted candidates will be notified.

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://ww.persolkelly.com.sg/policies. You acknowledge that you have read, understood, and agree with the Privacy Policy.

PERSOLKELLY Singapore Pte Ltd EA License No. 01C4394 I RCB No. 2007268E EA Reg. No. R1107631 Teresa Chan Poh Pin

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Company Description

Company Info

• Industry: Human Resources Management / Consulting
• Registration No.: 200007268E
• EA No.: 01C4394
• Company Size: 51 - 200 Employees
• Average Processing Time: 8 days
• Specific Location: Eunos