Regulatory Affairs Executive
4 days ago
Responsibilities:
1. Assisting in maintenance of the company’s Regulatory Affairs and applicable Jurisdiction Medical Device registration and registration maintenance.
2. Assisting in maintaining regulatory documents in good order.
3. Reviewing and updating external document master list, keeping up to date with changes in Regulatory Legislation and Guidelines
4. Gathering and updating Regulatory Registration Master List periodically to reflect up to date product status and regulatory information.
5. Preparing document for License and Regulatory Registration submissions and renewals on a timely manner.
6. Collecting and coordinating information and preparing regulatory documentations for submission to Regulatory Authorities or to commercial partners.
7. Collecting and coordinating information and preparing regulatory documentations for endorsement.
8. Contacting and arranging endorsement of regulatory certificates and licenses obtained from the authority
9. Assisting in identify incidents/ issues which requires advisory notice/ filed safety notice/ filed safety corrective action.
10. Assisting in reporting and vigilance activities.
11. Distributing User Feedback Questionnaires to customers and following up in a timely manner.
12. Distributing User Feedback Questionnaires to customers and following up in a timely manner.
13. Gathering and analyzing User Feedback data and preparing User Feedback Analysis report.
14. Assisting in the preparation for Regulatory Audit.
15. Participating in Internal Audits, Supplier/ OM’s period evaluation audit and External Audit.
16. Participating in Risk Management Team.
17. Performing other work related functions as assigned by superior
**Requirements**:
- At least Diploma/ Degree in Engineering field/ Chemistry/ Science related.
- Min 1 year of working experience.
- Must be able to work in Bandar Tasik Selatan area.
- Ability to work in team work and independently.
**Job Types**: Full-time, Permanent
Pay: RM2,515.12 - RM3,500.00 per month
Schedule:
- Monday to Friday
**Experience**:
- Regulatory Affairs: 1 year (required)
Work Location: In person
-
Regulatory Affair Executive/manager
5 days ago
Kuala Lumpur, Malaysia NuFarm Full timeRegulatory Affair Executive/ Manager Support Registration of Few Countries in SOUTHEAST Asia Grow a Better Tomorrow with Nufarm. Nufarm is the dependable partner behind thousands of agricultural success stories. Every day, growers around the world turn to our products and our people to help with the challenges of fighting disease, weeds, and pests, and...
-
Regulatory Affair
7 days ago
KL Eco, Kuala Lumpur, Malaysia PCCS Group Berhad Full timeJob DescriptionExecute and oversee regulatory submissions to ensure timely processing and compliance.Maintain proactive communication and good working relationships with regulatory authorities.Prepare, review, and maintain regulatory documentation and product registration files.Assist in the development, implementation, and maintenance of SOPs and other...
-
Regulatory Affairs Executives
5 days ago
Kuala Lumpur, Malaysia AG Staffing Malaysia Full time**Regulatory Affairs Executives (GDPMD/Regulatory Affairs of Medical Devices)** This position’s primary responsibility is handling Regulatory Affairs (RA) tasks, including product registration, license management, and compliance. This role is designed with Business Continuity Planning (BCP) in mind, ensuring that both staff members can support each...
-
Regulatory Affairs
7 days ago
Kuala Lumpur, Kuala Lumpur, Malaysia Novo Nordisk, Inc. Full timeRegulatory Affairs & Pharmacovigilance InternCategory: EducationLocation:Kuala Lumpur, Kuala Lumpur, MYRegulatory Affairs & Pharmacovigilance InternClinical/Medical/RegulatoryKuala Lumpur, MalaysiaAre you passionate about regulatory compliance and patient safety? Do you want to gain hands-on experience in ensuring medicines are safe and effective for...
-
Regulatory Affair Specialist
2 days ago
Kuala Lumpur, Kuala Lumpur, Malaysia Robert Walters Full timeAn exciting opportunity has arisen for a Regulatory Affairs Specialist to join a reputable organisation in Kuala Lumpur, supporting both Malaysia and Singapore operations. This role is perfect for someone who is passionate about ensuring regulatory compliance within the medical device sector and is eager to make a meaningful impact on patient safety and...
-
Regulatory Affairs Associate
2 days ago
Kuala Lumpur, Malaysia Bayer Full time**Job Main Purpose**: Primarily focused on regulatory compliance and meeting local regulatory milestones within the Bayer’s portfolios in Malaysia and Brunei. Overseeing documentation and archiving systems to ensure alignment with country regulations and internal Standard Operating Procedures (SOPs). This role involves assisting in the preparation and...
-
Regulatory Affair Executive
1 week ago
Lake Fields, Kuala Lumpur, Malaysia Public Medicare Group Sdn. Bhd. Full timeRoles and ResponsibiltiesRegulatory Documentation:Assist in the preparation, reviewal and submission of the document for product registration, renewal and various application.Maintain accurate and up to date records for all regulatory submission and approval.Compile the dossiers in accordance with the regulatory guideline and company...
-
Regulatory Affairs Specialist
5 days ago
Kuala Lumpur, Malaysia Ziwell Medical Sdn Bhd Full time**KEY FUNCTIONS** Develop regulatory strategies, handle and oversea regulatory submissions, such as product registrations, renewals, variations and post-market surveillance reports. Stay updated on changes in regulatory requirements and ensure organisation’s compliance with regulatory guidelines. Support and evaluate business development projects,...
-
Regulatory Affairs
2 weeks ago
Kuala Lumpur, Kuala Lumpur, Malaysia Talent Recruit Full timeJob Description Assisting in maintenance of the company's Regulatory Affairs and applicable Jurisdiction Medical Device registration and registration maintenance.Assisting in maintaining regulatory documents in good order.Reviewing and updating external document master list, keeping up to date with changes in RegulatoryLegislation and Guidelines.Gathering...
-
Regulatory Affairs Manager
2 weeks ago
Kuala Lumpur, Malaysia BIOMED GLOBAL SERVICES SDN BHD Full time**Position**: Regulatory Affair Manager **Industry**: Healthcare/ Medical Device **Responsibilities** - Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory. - Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA). - Initiate,...