Ra/qa Manager

6 days ago


หลกส กรงเทพมหานคร, Thailand Reeracoen Thailand Full time

**Overview**:
**Salary**:
70,000 THB ~ 100,000 THB**Industry**:
Medical, Manufacturing(Chemicals/Materials)- Responsible for Medical product registration, renewal, post approval changes and advertising approval by Thai FDA in compliance with Thai FDA regulations.
- Prepare registration dossier according to FDA requirement and prepare the documents for post approval changes liaising with FDA requirements.
- Timely communicate internal teams about updates from Thai FDA on registration status and regulatory relevant activities.
- All required elements for product registration are scheduled correctly and in place to meet the target filing and registration dates.
- Submission of Medical products for registration and follow up with FDA to obtain timely or

earliest approvals.- Able to manage in technical skills including regulatory and product quality perspectives.
- Coordinate with internal and global regulatory team to ensure that the registration dossier, packaging artworks meet the requirements of Thai FDA and properly manage and resolve the issues.
- Support and work closely with cross functional teams such as sales & marketing and quality team of relevant issues.
- Support and work closely with distributors in our territory to register new product and to maintain existing product in accordance with regulation in each country.
- Responsible for all activities of RA and relevant related RA activities.

**Qualifications**:
**Requirement**:

- Male or Female, aged between 30-45 years old
- Bachelor’s degree in related filed
- Minimum 5 years working experience in quality assurance, regulatory affairs area, and management (experience in medical product in an advantage)
- Have good experience in working with FDA in preparation of documents for the product registration until product marketing approval.
- Understanding of the rules and regulations medical products.
- Knowledge of relevant regulatory requirements and standards for medical devices (FDA, ISO13485, ISO 9000, 21 CFR 820, ISO14971, GMP requirements etc.)
- Leadership Character can work under high pressure
- Strong problem-solving and prioritization skills
- Good command in English (speaking, reading and writing)
- Good at computer skills (MS Office, MS Excel, Adobe etc.)**English Level**:
Level 3 - Business Level**Other Language**:
Thai, English

**Additional Information**:
**Benefit**:

- Provident fund 5%
- Medical insurance AIA
- Annual leave
- Performance bonus**Working Hour**:
9.00 ~ 18.00**Holiday**:
Sat - Sun, Public holiday**Job Function**:

- Regulatory Affairs



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