Regulatory - Senior Specialist

• Stay up-to date with the Regulatory landscape in each Marketing Territory.

• Independently and consistently ensure products compliance with applicable statutory and regulatory requirements by assessing, planning and executing Pre-market registration, Change notification, Special Authorization / Exemption Applications.

• Independently execute Post Market reporting timely and fulfill necessary requirements as part of post-market surveillance in documents and records keeping .

• Able to maintain compliance to advertisement regulations and respective labeling requirements in each marketing territory.

• Independently execute Other Authorities Compliances with relevant authorities / government bodies such as Poisons (MOH MY, HSA SG), Flammables & Hazardous Substance (HS) (NEA SG); SIRIM/ IMDA (MY; SG); DVS/ AVS (MY; SG).

• Independently execute yearly RA Audits internally and document findings effectively.

• Support external regulatory agency audits/ Principal audits/ Supplier audits, providing regulatory input to minimize potential for findings of non-compliance.

• Support internal audits of respective subsidiaries and associated companies in South East Asia on Regulatory matters.

• Support Routine Product Compliance Status (MDA, HSA, Other Authorities) Updates into ERP Systems, Verifying Product Compliances, updating product master list, IT batch uploads and logistic uploads for MDA Labeling database.

• Support Routine Updating of Registration master list (Regulatory Database).

• Actively participate in regulatory projects and provide inputs to process improvement.

• Proactive, high performance, result oriented and manage projects with ethical integrity.

• Excellent written and Verbal communication skills with the ability to listen, articulate and advocate.

• Possess good communication skills and ability to liaise with authorities, consultants, auditors and foreign manufacturers.

• Scientific knowledge must be able to digest complex data while keeping the big picture through good analytical skills.

• Technical system skills (e.g. MS office applications, databases, efficient online research).

• Good organizational skills, meticulous, planning and presentation skills.

• Demonstrate both creative and critical thinking skills.

• Good in understanding processes/workflows, keen to innovate and improve.

Biomed Global