Nov 27, 2020

Regulatory Affairs Engineer II / วิศวกรขึ้นทะเบียนสินค้า ระดับ II

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Northern Region Industrial Estate Lamphun

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this position is responsible for efficiently obtaining and processing the regulatory documents to support global registrations, maintaining product registrations for medical devices (local manufactured and imported) in Thailand and other APAC countries, ensuring prompt communications especially with manufacturing and Global Distribution Center operations by working closely with distributors, HOYA affiliates RA and Regulatory consultants. The person will be the key interface between RA and QA and GOP to execute day to day local RA activities to support product commercialization. Key Duties & Responsibilities • Under direction of the supervisor compile and maintain registration files for countries in APAC (primarily Thailand) • Ensure timely registration of new products and maintenance of registered product licenses in countries assigned by the supervisor. • Supports the business in obtaining timely regulatory documentation required to import/export and/or to obtain reimbursement approval • Communicate with consultants, agents, distributors, or other stakeholders in relation to registrations in process. • For post-market changes, ensure impact assessment is identified in the affected country and change notifications are submitted accordingly with minimum impact on product supply or internal processes. • Ensures that promotional and marketing material used is compliant with internal and external requirements • Monitors changes in local standards, regulations, guidance documents etc. and inform the relevant stakeholders in the company in case of impact. • Oversees the labeling change control activities with the labeling team at the manufacturing site. • Accountable for adverse event reporting review for complaints, AE, and FSCA reporting to an authority. • Maintain countries' registration status in the trackers. • Ensure Regulatory control for product release throughout the supply chain system. • Support departmental internal audit and the action items (if any)
  1. Minimally University Degree in Science (Pharmacy, Pharmaceutical Science) or related degree/diploma in Science, Engineering, and/or Biotechnology. Degree in Engineering or equivalent technical experience.
  2. Minimum 3 years submission experience in Regulatory Affairs in Medical Device industry in Thailand, SEA or APAC, preferably in a multi-cultural manufacturing environment.
  3. Experience with hands-on preparation of submission documents, handling regulatory submissions in Thailand for medical devices.
  4. Excellent interpersonal and communication skills
  5. Initiative to solve problem independently
  6. Able to work independently with minimal supervision
  7. Meticulous and attention to details.
  8. Strong technical writing and documentation skills
  9. Good English communication skills across different departments and organizations, knowledge in other Asian languages would be a plus.
- Click Apply Now via - Apply by Email - Send Application by Mail **** Out of an abundance of caution due to the concerns surrounding the current situation with the Coronavirus (COVID-19), we will be conducting our hiring process completely virtually. That means that all interviews and onboarding activities will be held online or over the phone. The health of our employees and candidates is our main priority and we hope you will forgive any inconvenience that may arise from this non-conventional approach. While the day-to-day approach has changed a bit during this time, our commitment to hiring the best talent in the industry and helping them to thrive both personally and professionally is stronger than ever. ******
โทรศัพท์ : 053-582-484
อีเมล : (อีเมลนี้ใช้สำหรับการติดต่อและสมัครงาน)
แฟกซ์ : 053-552-217
Northern Region Industrial Estate
Ban Klang Mueang Lamphun Lamphun
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