Regulatory Affairs and Quality Manager

2 weeks ago

กรงเทพมหานคร, Thailand B. Braun Ltd. Full time

**Duties and responsibilities**:

- Regulatory Affairs
- Plan, direct, and monitor regulatory affairs activities so that the organization has the permits, licenses, certificates, authorizations, and other approvals it needs to conduct its current and future business activities; and produce, sell, and distribute its goods and services
- Liaise with business unit managers to understand their short to medium-term business goals (for example introducing a new product, service, or operating process or entering a new market) and develop plans, cost estimates, and schedules for acquiring the necessary permits and other approvals
- Monitor regulatory and industry developments and advice senior management on the potential impact of current and future regulations on the operation of the organization
- Establish and maintain positive relationships with government agencies and other regulatory authorities; represent the organization in matters before regulatory, legislative, or industry standards agencies so that the organization’s interests are advanced
- Manage regulatory aspects of business relationships including the health authorities to ensure regulatory compliance and protect company interests
- Ensure regulatory function to be in compliance with corporate & regional policies, procedures and practice as well as local regulations
- Ensure effective management for product registration including the preparation and submission of regulatory dossiers/documents throughout product life cycle including advertisement permits.
- Quality Management
- Ensures the organization’s Quality Management System conforms to internal, regulatory and legal requirements.
- Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s products
- Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality
- Manage the cooperation with the government authorities to monitor, control and follow up the safety of the product used. As well as, provide the complete surveillance report to the Health Authorities and Head Office for the sake of the consumer and company
- Monitor and control Vigilance System for all B. Braun products in Thailand
- Lead product quality complaint management to be complied with External and Internal requirements
- Monitor and control product recall and FSCA (Field Safety Corrective Action) of B. Braun products in Thailand

**Professional competencies**:

- Have strong regulatory expertise in pharmaceutical / medical device with at least 5 years of regulatory experience in managerial position. Familiarity with medical device, cosmetic and other health care product regulation will be advantageous
- Strong management and leadership skills along with strategic thinking ability and a proven track record of regulatory successes
- Good knowledge of Legal Obligations
- Fluent in English ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills.

**Personal competencies**:

- Has direct experience in RA and QA field

**What we offer**:
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

**Closing date**:

- 26.04.2024

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