Regulatory Staff

2 weeks ago


Jakarta, Indonesia PT Abadinusa Usahasemesta Full time

**Role & Responsibilities**:

- Responsible to regulatory prepare, update, submit, and monitor the company on regulatory changes to be in compliant with regulatory requirements.
- Prepare and ensure company’s product compliance with the updated and applicable laws and standards
- Up-to-date on the current regulations related to medical and scientific laboratory devices
- Maintain proper documentation and records for regulatory purposes
- Prepare and assist regulatory audits and inspections.

**Qualification**
- Bachelor’s degree in Pharmacy/Chemistry/other related major
- Minimum 2 years in legal and regulatory roles (previously in medical/healthcare/scientific sector will be value added)
- Good understanding in medical device regulations, scientific industry regulations, purchasing procedures in private and government institutions, as well as e-katalog
- Strong knowledge of contract law and regulatory processes
- Proficient in English (written and spoken)
- Excellent communication, analytical, and detail-oriented skills.

Application Question(s):

- Do you have previous experience as Regulatory Affairs in medical/pharmacy industry?

**Education**:

- S1 (required)

**Experience**:

- regulatory affairs: 2 years (required)

Application Deadline: 02/28/2025


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