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Sr. Regulatory Affairs Specialist

Career

Sr. Regulatory Affairs Specialist

Your Exciting Role

Conduct research on product needs and prepare all required documents required for applying for and obtaining permits or certifications required by the company.
Create, propose and analyze strategies and options that can be taken to obtain permits or certifications required by the company.
Responsible for providing and managing the archive management and administration process for each product or company compliance registration according to the targeted deadline to obtain approval from the government or company stakeholders.
Coordinate and strive for all company compliance needs to obtain any required approvals or certifications, including but not limited to building communication and maintaining close relationships with registration authorities and related organizations/institutions, communicating with authorized agencies in obtaining permits or certifications required by the company.
Always keep abreast of changes in legislation and regulatory guidelines and analyzing their impact on the company's business activities; in connection with licensing of human medical devices (CPAKB, CDAKB, IDAK, NIE, TKDN), electronic medical records (EMR), fish medicine (CPOIB, Quality Testing, Marketing Permit), and/or animals.
Collaborate closely with R&D, Quality Assurance, Legal, and Operations teams to ensure regulatory compliance from early product development stages.
Ensure compliance with relevant national and international regulations (e.g., IVD, medical devices, ISO, GxP), and serve as the primary liaison between the company and regulatory authorities, including during clarification processes, audits, and inspections.

The most established precision molecular diagnostics company in Indonesia

Find Us

Mon - Fri: 9 a.m. - 6 p.m.

i3L Campus @ Lvl. 3
Jl. Pulomas Barat No.Kav.88, RT.4/RW.9, Kayu Putih, Pulo Gadung,
Jakarta Timur 13210

hello@nusantics.com

+62 (21) 509 194 30

Home

Career

Sr. Regulatory Affairs Specialist

Career

Sr. Regulatory Affairs Specialist

Your Exciting Role

Conduct research on product needs and prepare all required documents required for applying for and obtaining permits or certifications required by the company.
Create, propose and analyze strategies and options that can be taken to obtain permits or certifications required by the company.
Responsible for providing and managing the archive management and administration process for each product or company compliance registration according to the targeted deadline to obtain approval from the government or company stakeholders.
Coordinate and strive for all company compliance needs to obtain any required approvals or certifications, including but not limited to building communication and maintaining close relationships with registration authorities and related organizations/institutions, communicating with authorized agencies in obtaining permits or certifications required by the company.
Always keep abreast of changes in legislation and regulatory guidelines and analyzing their impact on the company's business activities; in connection with licensing of human medical devices (CPAKB, CDAKB, IDAK, NIE, TKDN), electronic medical records (EMR), fish medicine (CPOIB, Quality Testing, Marketing Permit), and/or animals.
Collaborate closely with R&D, Quality Assurance, Legal, and Operations teams to ensure regulatory compliance from early product development stages.
Ensure compliance with relevant national and international regulations (e.g., IVD, medical devices, ISO, GxP), and serve as the primary liaison between the company and regulatory authorities, including during clarification processes, audits, and inspections.

The most established precision molecular diagnostics company in Indonesia

Find Us

Mon - Fri: 9 a.m. - 6 p.m.

i3L Campus @ Lvl. 3
Jl. Pulomas Barat No.Kav.88, RT.4/RW.9, Kayu Putih, Pulo Gadung,
Jakarta Timur 13210

hello@nusantics.com

+62 (21) 509 194 30

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