Job Description

$7K + AWS + VB + allowance5 working days, Mon - Fri, normal office hoursLocation: CentralResponsibilities

• Assist the department head in managing the department activities, and as a designee during his/her absences. Tasks include but not limited to team capacity planning, process improvement, etc.
• Formulate the annual budget and manages the regulatory budget as needed. This include the monthly forecast spending review against the budget.
• Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or changed product launches.
• Write and file appropriate pre-market notification submission to FDA; Write and maintain technical file / design dossier for CE marking a Class I, IIa and III medical devices; Write and maintain submission to Health for device licensing.
• Prepare CSTD submission package to Singapore Health Science Authority. Maintain the dealer licenses and product licenses/clearance for importation and sales
• Support the international regulatory specialist within the global regulatory affairs department with product registration in accordance with their local regulatory requirements.
• Maintain current knowledge and stay abreast with the polices/guidance, regulations, EU medical device regulation and Singapore HSA regulation pertaining to legal distribution of medical products. Implements and drives any new medical device requirement within the quality system environment.
• Review and approve scientific and promotional materials as well as documentation change requests to ensure regulatory compliance.

Requirements

• Minimum Degree/Diploma in relevant fields or equivalent.
• Minimum 3 years of relevant experience.
• Experiences in regulatory affairs in medical devices is a plus.
• Excellent communication and interpersonal skills

Competitive remuneration package will be offered to the shortlisted candidate.Interested candidates, please send your updated CV in MS Words format stating your last drawn salary, expected salary, notice period and reason for leaving last / past employment(s) and email to recruit@caed.com.sg for priority processing.To find out more job opportunities, visit Career Edge Asia at www.caed.com.sg for all job listings.Please connect us via LinkedIn as follows for efficient messaging:Do Join us at TELEGRAM by searching \xe2\x80\x9cCAREER EDGE JOB OPPORTUNITIES\xe2\x80\x9d to receive fast job alert!Attn: Jace Tay (Registration No.: R1331152)CAREER EDGE ASIA PTE LTD
EA Licence Number: 13C6678
To find out more job opportunities, visit Career Edge Asia at www.caed.com.sg for all job listings.
Email: recruit@caed.com.sgSocial Share:More Information

• Salary Offer $5000-$7000

Career Edge Asia