Regulatory Affairs Associate

1 week ago


Kuala Lumpur, Malaysia Emprego MY Full time

**About the Position**

**Role**:

- Review, Prepare, compile and submit all documentations required for medicaldevice submissions, license renewal, new device registrations and change notification with relevant regulatory agencies (MDA, NPRA, Sirim)
- Manages and implements internal regulatory tracking / control systems.
- Keeps abreast of regulatory requirement and changes.
- Liaise with regulatory agencies on defined matters.
- Manages Post Market Surveillance activities (reporting of adverse event, FCA, recall to regulatory agency)
- Work closely with Global RA partners to obtain registration documents.
- Participate in monthly/bi-monthly/quarterly regulatory meeting with Global RA partners.
- Establish close interaction with local business team via monthly/bi-monthly/quarterly regulatory meeting.
- Anticipate regulatory obstacles and emerging issues throughout the device registration cycle. Provide solution or escalate if needed to overcome the issue.
Involve in GDPMD internal and external audit annually.
- Evaluate new requirement and provide business impact if any.
- Reviews and approves local labelling to ensure proper process is in place locally.
- Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
- Bachelor’s degree in Science or related discipline.
- Good knowledge in Malaysia Medical Device Regulation
- Preferred 3 to 5 years of Regulatory Affairs experience in the Medical Device industry
- Good English language and communication skills.
- Experience in cross functional working in a matrix organization.
- Can works independently with general supervision.

**Khim Goh**

**03-27138830**

**Visit our corporate website**:
no - Principals only. Recruiters, please don’t contact this job advertiser.
no - Please, no phone calls about this job
no - Reposting this message elsewhere is NOT OK.



  • Kuala Lumpur, Kuala Lumpur, Malaysia Munich Re Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Expert to join our team in Kuala Lumpur. As a key member of our risk management department, you will be responsible for ensuring compliance with regulatory requirements and internal standards.Your primary duties will include:Providing advice on regulatory matters;Coordinating with business...


  • Kuala Lumpur, Malaysia Medtronic Full time

    **Careers That Change Lives **We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Quality & Regulatory Affairs and help shape policies that change lives. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    Regulatory Affairs Specialist RoleSyneos Health, Inc. is a leading biopharmaceutical solutions organization committed to accelerating customer success.We focus on translating clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Job Summary:The Senior Clinical Research Associate I will perform regulatory...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Food Industry Asia (FIA) Full time

    We are looking for an ambitious and experienced Regulatory Affairs Manager who will lead projects and mission-critical work focusing on Ingredients, Codex standards regulatory development to support innovations across the Asia region. Reporting to the Head of Science & Regulatory Affairs, this role will be responsible for implementing FIA strategy in driving...


  • Kuala Lumpur, Kuala Lumpur, Malaysia CapitaLand Full time

    Job DescriptionThe Manager of Regulatory Affairs and Compliance will be responsible for overseeing our compliance programs and ensuring that we meet all relevant regulatory requirements. This includes implementing and monitoring control systems to prevent violations of legal rules and internal policies.The successful candidate will have a strong background...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Xendit Full time

    Xendit provides payment infrastructure across Southeast Asia, empowering businesses to grow exponentially. With a focus on Indonesia, the Philippines, and Malaysia, we process millions of transactions monthly, serving thousands of customers.We're committed to building the most advanced payment rails for Southeast Asia, making payments simple, secure, and...


  • Kuala Lumpur, Malaysia BI (Malaysia) Sdn. Bhd Full time

    **The Position**: - To achieve timely & successful product registrations in accordance with corporate & local strategies. - To update the Company on new Regulations and Guidelines, and to ensure the Company complies with the local legislations & industry codes governing the import and control of therapeutic products. - To ensure compliance with Company...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Pasona Full time

    Job OverviewWe are looking for a skilled Regulatory Affairs Executive to join our team at Pasona. As a key member of the regulatory affairs department, you will be responsible for ensuring compliance with government regulations and guidelines.About the Role:You will be responsible for liaising with government offices, authorities, and regulatory consultants...


  • Kuala Lumpur, Kuala Lumpur, Malaysia EPM Scientific - Phaidon International Full time

    EPM Scientific - Phaidon International is a leading medical device company dedicated to improving healthcare through innovative medical devices.We're seeking a highly motivated and detail-oriented Global Regulatory Affairs Executive to join our team.In this role, you'll be responsible for ensuring that our medical devices comply with all regulatory...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Touch 'n Go Group Full time

    We fuel the ideas and ambitions of our people with an environment built on Our DNA of Love, Entrepreneurship, Agility, and Passion – LEAPWe are a culture that empowers everyone to innovate and create solutions that will leave a positive impact on our communities and our nation, Touch 'n Go will always be here to inspire our talents to grow as leaders and...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Polylab Biotech Sdn Bhd Full time

    **About the Role**We are seeking a detail-oriented Regulatory Affairs Executive to join our team at Polylab Biotech Sdn Bhd.This is an exciting opportunity for someone who thrives in a dynamic environment and has excellent analytical skills.The successful candidate will be responsible for managing product registrations, renewals, and dossier development.


  • Kuala Lumpur, Kuala Lumpur, Malaysia Pasona Full time

    Regulatory Affairs Executive Job DescriptionPosition Title: Regulatory Affairs ExecutiveJob ID: 23639Salary: 7000~8000 (RM)Location: [Location not specified]Job Responsibilities:Liaise with government offices, authorities, and regulatory consultants on matters pertaining to regulatory activities, licenses, and permits for developing new and existing...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Berjaya Sompo Insurance Berhad Full time

    Job Overview:Berjaya Sompo Insurance Berhad is committed to maintaining a strong culture of compliance and risk management. We are seeking a Regulatory Affairs Executive to assist in ensuring that the company remains in compliance with all relevant regulatory requirements.Key Responsibilities:Assist in reviewing regulatory guidelines and identifying...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Bank of America Full time

    Job SummaryWe are seeking a highly skilled and experienced professional to join our team as a Vice President of Regulatory Affairs. In this role, you will play a key part in shaping our compliance and operational risk management strategies.Main ResponsibilitiesDevelop and implement compliance and operational risk management policies and procedures.Lead the...

  • Regulatory Affairs

    2 weeks ago


    Kuala Lumpur, Malaysia Agensi Pekerjaan EPS Consultants Sdn Bhd Full time

    Client Background: MNC Company Industry: Healthcare Location: KL Headcount: 1 Position Title: Regulatory Affairs & Compliance Executive Tenure: Permanent Remuneration: up to RM4000 + Contractual Bonus (1-mth) + Performance bonus + Medical Benefit .Liase with relevant regulatory bodies to submit & collect documents/license as required, attend regular...

  • Regulatory Affairs

    2 weeks ago


    Kuala Lumpur, Malaysia EPS Full time

    **Regulatory Affairs & Compliance Executive - Kuala Lumpur** - Liaise with relevant regulatory bodies to submit & collect documents/license as required, attend regular seminars/meetings to receive latest information of the industry. At the same time, responsible in ensuring all required licenses is valid and all requirements to run the business are...


  • Kuala Lumpur, Kuala Lumpur, Malaysia SWIFT Full time

    Join Our Compliance TeamWe're currently seeking a Compliance Assurance Specialist to join our Compliance & Regulatory Affairs team. As a key member of our team, you'll play a critical role in ensuring that our operations are aligned with regulatory requirements. Your primary responsibilities will include maintaining our Compliance framework, managing our...


  • Kuala Lumpur, Malaysia Pfizer Full time

    The Regulatory Affairs Protege for GRS IRSP-Asia is responsible for assisting GRS-RSPI Asia in the preparation and submission of registration documents to Regulatory Authority and other administrative tasks. - Administrative Duties: Handle ad-hoc administrative tasks Records and documentation maintenance (filing, photostating, store maintenance, dispatch...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Ezypay Full time

    We're looking for a seasoned Regulatory Affairs Specialist to join our Business Compliance team at Ezypay.The ideal candidate will have a deep understanding of Payment Services regulations and AML/CTF laws, as well as experience in developing and implementing compliance programs.Key Responsibilities:Collaborate with cross-functional teams to ensure...


  • Kuala Lumpur, Kuala Lumpur, Malaysia MUFG Investor Services Full time

    Job SummaryLiaise with investment managers, vendors, and auditors for day-to-day operational issues.Prepare or co-ordinate and review all client financial reporting deliverables and associated reports as required.The Senior Associate Director – Financial & Regulatory Reporting will be responsible for leading our financial reporting team, ensuring all...