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:

Commercial RA Singapore role

• 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

Interested applicants, please submit your CVs to Lyn Fu Yee Chen (R1110796) through the \'Apply Job\' button.

Only shortlisted applicants will be notified.

All applications will be handled with strict confidentiality.

Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by Manpower for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012.

Lyn Fu Yee Chen (R1110796)

Manpower Staffing Services (S) Pte Ltd

EA License No: 02C3423

Additional Information

Career Level

Senior Executive

Qualification

Not Specified

Years of Experience

5 years

Job Type

Full-Time

Job Specializations

,

Company Overview

Manpower is the global leader in contingent and permanent recruitment workforce solutions. It is part of ManpowerGroup, the world leader in innovative workforce solutions, which creates and delivers high-impact solutions that enable clients to achieve their business goals and enhance their competitiveness.

Manpower has provided organizations in Singapore with a continuum of staffing solutions from the incidental to the strategic since 1996, working with businesses to help them win. In the Human Age, where talent has replaced access to capital as the key competitive differentiator, Manpower Singapore leverages its trusted brand to develop a deep talent pool, providing clients with access to the people they need, fast. Manpower Singapore creates powerful connections between organizations and the talent they need to enhance their competitiveness and unleash their workforce potential. By creating these powerful connections, we help everybody achieve more than they imagined, and power the world of work.

See what is humanly possible at manpower.com.sg.

Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by Manpower for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012. To learn more about ManpowerGroup\'s Global Privacy Policy, please visit https://www.manpower.com.sg/privacy-policy

Additional Company Information

Registration No.

.

EA No.

02C3423

Company Size

51 - 200 Employees

Industry

Human Resources Management / Consulting

Singapore Post