Regulatory Affairs Engineering II (Medical Devices)/วิศวกรขึ้นทะเบียนสินค้า ระดับ 2 (Medical Devices)Hoya Lamphun Ltd.

Degree

Overtime pay
Performance bonus
Free shuttle bus

Main Purpose of Job
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.
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 license 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 labelling change control activities with labelling team at the manufacturing site.
Accountable for adverse event reporting review for complaints, AE and FSCA reporting to authority.
Maintain countries registration status in the trackers.
Ensure Regulatory control for product release throughout supply chain system.
Support departmental internal audit and the action items (if any)
Other activities as needed assigned by the supervisor in support of regulatory processes and/or registrations
Education:
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.
Experience:
Minimum 3 years submission experience in Regulatory Affairs in Medical Device industry in Thailand, SEA or APAC, preferably in a multi-cultural manufacturing environment.
Skills/ Knowledge/ Ability:
Experience with hands-on preparation of submission documents, handling regulatory submissions in Thailand for medical devices.
Excellent interpersonal and communication skills
Initiative to solve problem independently.
Able to work independently with minimal supervision
Meticulous and attention to details.
Strong technical writing and documentation skills
Good English communication skills across different departments and organizations, knowledge in other Asian languages would be a plus.
Only short-listed will be notified. Attractive remuneration package will be offered to the successful candidate.
 Interested candidates should send in their applications, stating in full, qualifications and experience, as well as current and expected remuneration, and a recent photograph,