Job Description Summary

Ensure timely approvals for respective product line by plans on all product registrations, manage all product registrations' compilation, submissions, renewals, and ongoing compliance with relevant authorities in Malaysia and Indonesia.
Interacts with regulatory agencies to expedite approval of pending registration and answers any questions on product documentation.

Main responsibilities
• Prepare, compile, submit and maintain product registrations related to registration, renewal, and license amendments of medical devices, till approval process with the Malaysian Medical Device Authority (MDA) & Ministry of Health (Kemenkes).
• Monitor submission status and support timely responses to deficiency letters and regulatory authority requests, ensuring accurate documentation of all interactions.
• Liaise with regulatory authorities, conformity assessment bodies (CAB), and other relevant authorities.
• To keep abreast of local regulatory updates, guidelines and new regulations, and its implementation.
• Ensure that the product, packaging, and labeling of the current and new products comply with the regulatory requirements.
• Perform change impact assessment for Malaysia and Indonesia.
• Perform advertisement and promotional material review in accordance with local regulations.
• Other tasks as assigned.

Qualification
• Strong command of English and Bahasa Malaysia (verbal and written).
• Strong understanding of Malaysia and Indonesia regulations.
• Ability to ensure accuracy in documentation, packaging, and product compliance.
• Ability to manage multiple tasks, prioritize tasks effectively, and meet deadlines.

Job Description

Who We Are
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

Job Description

Ensure timely approvals for respective product line by plans on all product registrations, manage all product registrations' compilation, submissions, renewals, and ongoing compliance with relevant authorities in Malaysia and Indonesia.
Interacts with regulatory agencies to expedite approval of pending registration and answers any questions on product documentation.
 

Key Responsibility
•    Prepare, compile, submit and maintain product registrations related to registration, renewal, and license amendments of medical devices, till approval process with the Malaysian Medical Device Authority (MDA) & Ministry of Health (Kemenkes).
•    Monitor submission status and support timely responses to deficiency letters and regulatory authority requests, ensuring accurate documentation of all interactions.
•    Liaise with regulatory authorities, conformity assessment bodies (CAB), and other relevant authorities.
•    To keep abreast of local regulatory updates, guidelines and new regulations, and its implementation.
•    Ensure that the product, packaging, and labeling of the current and new products comply with the regulatory requirements. 
•    Perform change impact assessment for Malaysia and Indonesia.
•    Perform advertisement and promotional material review in accordance with local regulations.
•    Other tasks as assigned.
 
Qualification
•    Strong command of English and Bahasa Malaysia (verbal and written).
•    Strong understanding of Malaysia and Indonesia regulations.
•    Ability to ensure accuracy in documentation, packaging, and product compliance.
•    Ability to manage multiple tasks, prioritize tasks effectively, and meet deadlines.

Culture and Benefits

Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.

Required Skills

Optional Skills

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Primary Work Location

MYS Kuala Lumpur - Damansara Heights

Additional Locations

Work Shift