Quality Assurance and Regulatory Affairs Lead

2 weeks ago

Jakarta, Indonesia Thermo Fisher Scientific Full time

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

The Regulatory Affairs and Quality Supervisor (Lead) is responsible for execution of PT Indonesia quality assurance, registration policies and standards, and ensures the regulatory compliance to local and international regulations. The role will call for a strong strategic orientation in order to drive the right strategic decisions for quality pathways that will optimize the time to market and ensure on time registration and maintenance of operational licenses and government approvals.

**What will you do?**
- Pre-market registration/listing and post-market surveillance activities for IVD and medical device with the Ministry of Health and other government officials
- Establish and maintain certification to IDAK, CDAKB, and other regulatory standards, and RUO listing with MOH
- Review of dossier files before submission and collaborating with Global & Regional Regulatory team
- Report to local authorities in a timely manner on post market surveillance activities (e.g., Adverse Event Reporting and Field Safety Corrective Action)
- Responsible for developing and implementing quality management systems in our Indonesian entity
- Responsible for the inspection and management (including training) of service providers to ensure they meet local regulations and quality standards for medical device and IVD
- Develop and maintain the quality management system based on national regulatory standards.

**How will you get here**

**Education**:

- Bachelor's degree in biomedical engineering, pharmacy, or equivalent field. Equivalent experience in a related field will also be considered

**Experience**:

- 5+ years of regulatory experience in either IVD and/or medical device industries.
- Good understanding in CDAKB requirements (Completed CDAKB training is an advantage)
- Proven experience in Project management in lead regulatory
- Involvement in industry associations will be an advantage (e.g., APACMed, GAKESLAB).
- Successful experience in communicating with regulatory agencies and customer facing experience

**Knowledge, Skills, and Abilities**
- Must possess strong organizational skills and be able to prioritize multiple projects concurrently
- Knowledge of IVD/MD registration, RUO submission process in Indonesia
- Working experience in direct liaising with the authority and ability to respond optimally to authority queries.
- Proficient in both verbal and written communication skills in Indonesian and English and strong presentation skills.
- Strong interpersonal skills, able to remain calm, professional, respectful, and positive
- Work as a team member in a fast-paced environment with limited supervision
- Skilled at building strong connections with colleagues from departments in a collaborative work setting, as well as with partners
- A collaborative individual who can also demonstrate the ability to work independently
- Positive attitude, proactive approach, and a willingness to learn

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. A one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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