Regulatory Affairs Associate

Regulatory Affairs Associate


Regulatory Affairs Associate

Details of the offer

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Job Description:

The Role:

Reporting into the Indonesia Regulatory Affairs (RA) leader, you will be responsible for the Regulatory Affairs & Quality Compliance (RAQC) for the Health Care Business (HCB) and Consumer Health Care Business (CHCB).

Successful execution is key to perform RAQC function to support business growth, mitigate the compliance risk and achieve long term financial goals for 3M HCB and CHC businesses.


1. Responsible for all activities pertaining to the relevant regulatory licenses and requirements for the 3M Healthcare establishment in the country.

2. Responsible for all pre-market regulatory clearances for all imported products and OEM products in the country, e.g.:

- Determine registration plans with business segments to ensure right business direction to achieve company goals.
- Articulate the registration requirements to ensure the collected information useful for submission plan.
- Review registration document and able to address the gap of technical deficiencies.
- Compile documentation and ensure completeness of registration dossier.
- Submit registration dossier and follow through until regulatory clearance is obtained.
- Establish and maintain Registration Planner and Listing for relevant countries as deemed appropriate.

3. As appropriate, act as the main focal point for distributors pertaining to regulatory activities shown below, e.g.:

- Execute the submission of registration dossier.
- Follow-up and ensure that submission is done and regulatory clearance obtained.
- Periodically monitor the registration performance done by distributor.
- Support to smoothen the registration assessment in registration cycle

4. Responsible for all post-market regulatory activities for all registered products in the country, e.g.:

- Execute all warranted FSCA and follow-up all through until closure, including preparation and submission of relevant FSCA reports to regulatory body.
- Submit and follow up the adverse event report to ensure the compliance of government regulation.
- Review and approve promotional materials to ensure all documentation in line with registration claims and country regulatory requirements.
- Collaborate with Quality to ensure the custom labeling activities in line with country regulatory requirement.

5. Monitor and promptly respond the changes in regulatory environment and participant in relevant industry meetings and take action to react to changes to ensure that 3M complies with relevant requirements.

6. Develop and maintain regulatory systems and tools to drive operational excellence for effective data tracking and remain regulatory data integrity

7. Develop standard operating procedures to support good distribution process and manage the regulatory control premise.

8. Remain good rapport with regulatory authority and regulatory industry to assure the partnership and improve the transparent communication of regulatory policy.


- Education: Bachelor of Science or Biomedical Science related; Pharmacist is a plus.
- Has 2 to 3years of Regulatory work experience, preferably in the medical device industry.
- Relevant work experience in the health care business is required.
- Knowledge of quality management systems or health care regulatory requirements.
- Knowledge of ASEAN medical devices regulatory requirement.
- Communicates well in English, and has good inter-personal skills.
- Able to proactively and independently work on regulatory support.
- A team player who is able to support multiple tasks and lead the regulatory direction for the Business.

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Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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