Job Description

• 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
• Strong interpersonal and communication skills.

Location : Beach Road

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

Interested candidates, please forward your resume to teresa_chan(a)persolkelly.com

PERSOLKELLY Singapore Pte Ltd EA License No. 01C4394 I RCB No. 200007268E EA Reg. No. R1107631

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates collecting, using and disclosing my personal data for the purposes set out in the Privacy Policy which is available at www.persolkelly.com.sg I also acknowledge that I have read, understood, and agree to the said Privacy Policy

Additional Information

Career Level

Senior Executive

Qualification

Bachelor\'s Degree, Post Graduate Diploma, Professional Degree, Doctorate (PhD)

Years of Experience

5 years

Job Type

Full-Time

Job Specializations

,

Company Overview

PERSOLKELLY is one of the largest recruitment companies in Asia Pacific providing comprehensive end-to-end workforce solutions to clients.

Headquartered in Singapore, the company was established in 2016 and is a joint venture between Kelly Services, Inc. and affiliates of PERSOL HOLDINGS Co. Ltd.

Today, PERSOLKELLY operates more than 45 offices across 13 markets including Australia, China, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Taiwan, Thailand, and Vietnam.

Our deep market understanding and industry expertise, honed over four decades of operations in Singapore, gives us an edge in driving business change and empowering your organisation to overcome future HR challenges. We combine our expertise with genuine human insights to provide strategic solutions for your HR needs. Our team will partner with you to enhance your HR practices, so you can confidently achieve more.

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its local and overseas subsidiaries and affiliates collecting, using and disclosing your personal data to prospective employers/companies based in any country for purposes of evaluating suitability for employment, conducting reference checks, administering employment related services, complying with Government\'s COVID-19 health advisories and such other purposes stated in our privacy policy.

Our full privacy policy is available at https://www.persolkelly.com.sg/policies. If you wish to withdraw your consent, please drop us an email to let us know. Please feel free to contact us if you have any queries.

(NOTE: any resumes or job applications sent to this data protection mailbox will NOT be attended to as it is solely for the purposes of personal data protection related feedback.)

For more information, please visit www.persolkelly.com.sg

Additional Company Information

Registration No.

200007268E

EA No.

01C4394

Company Size

201 - 500 Employees

Average Processing Time

6 days

Industry

Human Resources Management / Consulting

Benefits & Others

Regular hours, Mondays - Fridays

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