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Raqa Junior Executive
1 week ago
KEY RESPONSIBILITIES
Product Registration/Licensing Management
- Manage product registration, including dossier preparation, change notification, reregistration, internal audit and CAB audit for all sister companies' submission, monitor progress and meet timelines
- Communicate and work closely with all relevant stakeholders, such as authorities, sales team, and suppliers to deliver regulatory outcomes that enable business plans.
- Support the RAQA manager in developing strategic method for product registration
- Obtain timely renewal of product licenses and maintain registration database.
- Manage all licenses or certificates to ensure medical devices comply with any other applicable regulatory agency requirements e.g. SIRIM.
- Keep update of the regulatory changes, especially in MDA Guidance and MDA Announcement
- Prepare and maintain company stationeries, marketing materials, documents, and reports
- Provide operations support and documentation support for managers
- Attend meetings and special projects when needed
RA/QA Matters Handling
- Manage post-market surveillance activities such as customer complaints, adverse events, and field safety corrective actions, including product recalls. Collaborate with sales team/logistic team and the manufacturer.
- Implement and maintain the quality management system especially in documentation and support site's period Management Review Meeting with GDPMD requirement
- Facilitates and conduct the periodic Internal Audit and External Audits as per GDPMD requirements and Medical Device Authority (MDA)
- Work closely with Conformity Assessment Body (CAB) in arranging GDPMD Surveillance or Recertification Audits
- Support the audits and follow up with the close of audit findings
JOB REQUIREMENTS
Requirement for the Position
Education:
A bachelor's degree from an accredited college or university is required. A Master's degree or PhD is advantageous. Preference is given to degrees in technology or science.
Experience
- A minimum 1 year of working experience in RA/QA experience. Comprehensive knowledge of regulatory requirements for the medical device industry is essential.
- Experience in preparing and submitting regulatory dossiers for relevant countries and reviewing, interpreting, and implementing changes in legislation into processes and procedures is necessary handling of MedCast Submission registration and acknowledgment of MDA Guidance is preferred.
- Effectively prioritises workload and manages time to complete multiple projects within established time-lines and goals with mínimal supervision in a fast-paced, interrupt-driven environment.
- Honest, flexible, dependable, self-motivated team player with the ability to work autonomously
- Strong interpersonal skills, effective written and verbal communication, problem-solving and decision-making skills and ability to interact with all levels of management
- Ability to work in a cross-functional team environment and a flexible team-oriented perspective
- Effectively prioritises workload and manages time to complete multiple projects within established time-lines and goals with mínimal supervision in a fast-paced, interrupt-driven environment
Job Types:
Full-time, Permanent
Pay:
RM2, RM2,500.00 per month
Benefits:
- Health insurance
- Maternity leave
- Professional development
Schedule:
- Monday to Friday
Supplemental pay types:
- Yearly bonus
Education:
- Bachelor's (preferred)
Experience:
- RA/QA: 1 year (preferred)
Language:
- English (preferred)
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