Regulatory Affairs Exec – Medical Devices (Malaysia/CE-FDA)

Vital; Kuala Lumpur; Vor Ort; MYR 50.000 - 80.000; Vollzeit

Zusammenfassung

Vital in Kuala Lumpur is seeking a Regulatory Affairs professional to ensure compliance of medical device products with MDA, CE, and FDA standards. The role involves registration, certification renewals, and close interaction with government bodies to obtain timely approvals.

The ideal candidate has at least 1 year in regulatory affairs within pharma or medical devices, with strong communication and documentation skills, and familiarity with Malaysia’s regulatory landscape.

Qualifikationen

• Bachelor’s degree in Biomedical Engineering or related field.
• Minimum 1 year of regulatory affairs experience in pharma or medical device industry.
• Excellent understanding of Malaysia regulatory landscape (MDA) and CE regulations.
• Excellent communication and interpersonal skills, able to liaise with internal and external stakeholders.
• Fresh graduates are encouraged to apply.

Aufgaben

• Ensure regulatory compliance of company products and review documentation for MDA, CE, FDA, and other regions.
• Carry out product registration, system certification, renew certificates, and apply for certificate replacement.
• Follow up on registration and internal review, submit information to complete applications.
• Coordinate with government and industry departments to obtain timely registration approvals.
• Stay up-to-date with latest regulatory requirements and guidelines in the medical device industry.
• Liaise with regulatory authorities and stakeholders to address queries and ensure timely approvals.
• Provide regulatory guidance to product development and marketing teams.
• Participate in development of regulatory strategies and policies for company growth.

Kenntnisse

Regulatory knowledge

Communication

Stakeholder liaison

Documentation

Ausbildung

Bachelor's degree in Biomedical Engineering

Jobbeschreibung

Vital in Kuala Lumpur is seeking a Regulatory Affairs professional to ensure compliance of medical device products with MDA, CE, and FDA standards. The role involves registration, certification renewals, and close interaction with government bodies to obtain timely approvals.

The ideal candidate has at least 1 year in regulatory affairs within pharma or medical devices, with strong communication and documentation skills, and familiarity with Malaysia’s regulatory landscape.