JOB DESCRIPTION:

The regulatory & labeling compliance specialist will ensure that only registered/licensed products are allowed for shipment to respective regulated APAC countries from the Molecular Diagnostics (MDx) Regional Distribution Centre in Singapore. In addition, the specialist is also responsible for ensuring compliant country specific addendum labeling are maintained and correctly assigned to products batches for by-packing.

Major Responsibilities

• Maintenance of country specific product addendum labeling requirements and materials database and ensures accurate assignment of addendum labeling materials, according to countries and internal requirements to product batches for each sales order.

• Manage internal change request on country specific addendum labelling and communicate to relevant functions for implementation.

• Ensure all required countries registration/license/permits and country specific addendum product labeling are in place before effecting the change request for legal control release.

• Primary contact point for MDx Global/Affiliate Regulatory Affairs and Labeling Specialist for matters related.

• Support continuous improvement in the legal control, labels control and by-packing processes.

• Support internal and external audits related to regulatory & labeling compliance activities.

• Maintain positive and cooperative communications and collaboration with all levels of stakeholders in the MDx supply & distribution chain.

Requirements:

• Degree in Life Sciences, Biomedical Science, Pharmaceutical Science, Engineering or other relevant disciplines.

• 2-3 years of experience in pharmaceuticals/medical device industry preferably in areas such as regulatory/quality compliance, labeling change control management or product repackaging/relabeling.

• Basic understanding of Medical Device Regulations and Quality Management System.

• Knowledge of SAP and Excel is an advantage.

• Good English language proficiency.

• Strong written and communication skills.

• Meticulous and strong organizational skills

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

AMD Molecular

        

LOCATION:

Indonesia > Pondok Indah : Wisma Pondok Indah 2

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 50 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)