Company Description

Bain Medical Equipment (Guangzhou) Co., Ltd is China's largest manufacturer of blood purification products, specializing in innovative solutions for hemodialysis equipment and disposables. Headquartered in the Guangzhou Economic & Technological Development Zone, the company has been a global partner in healthcare since 2003. Bain Medical exports to over 60 countries across Europe, Asia, the Middle East, Africa, and South America, with a workforce exceeding 2,000 employees. Certified for ISO 13485, GMP regulation, CFDA, and CE, Bain Medical is committed to quality, integrity, and continuous innovation to lead global advancements in the healthcare industry.

Role Description

Responsible for ensuring compliance with national regulations governing controlled chemical substances used in medical or production processes. The role includes implementing internal control systems, training staff in safe handling and storage, maintaining accurate records, and preparing regulatory documentation for submission to the Ministry of the Interior. The Technical Representative oversees audits, inventory control, and ensures adherence to legal and technical standards for lawful substance management.

Qualifications

Job responsibilities:

a) Implement internal control measures and mechanisms for the entity it represents to ensure the lawful use of substances subject to regulation.

b) Train personnel at the representative's facility on handling, storing, and transporting regulated chemical substances used in their work environments, along with implementing proper safety protocols. This training should ensure lawful use of these materials while preventing diversion, in compliance with technical standards established by the competent authority.

c) Technically compliant with formats provided by the Ministry of the Interior, the documentation

must include production, usage, required quotas, and loss/gain methodologies for each substance during the certification and renewal process. This includes systems of measurement, storage capacity, annual projected acquisition estimates for substances under regulatory oversight, annual production capacity, descriptions of production processes, and substance interventions in production processes. product development, consumption indices, installed capacity for use, formulations, and production capacity; and,

d) Implement good practices for the control of substances subject to regulation to ensure their

lawful use by developing the Manual for the Management of Substances Subject to Regulation,

which includes:

1.-Responsibilities of personnel handling substances subject to supervision (warehouse keeper, transporter, production supervisor, and others);

2.-The administrative procedures for its management;

3.-Production processes, flowcharts, and the establishment of consumption indices;

1. -Production order format and/or consumption records;5.-List of equipment used in the production process, including production capacity, usage, and

maintenance plan.

1. -Good storage, packaging, distribution, and transportation practices.

2. -Verification procedure for suppliers and/or buyers of these substances, applying the know-your customer procedure.

3. -Metrology procedures implemented in the company: measuring instruments and equipment to be used must be calibrated according to the equipment's specifications by authorized institutions, with records of calibration and verification results maintained.

4. -Inventory adjustment registration procedures.

10.-Procedure for implementing new formulations containing substances subject to regulatory oversight.

11.-Procedure for physical inventory.

12.-Procedures for archiving documents that technically support the use of substances classified for monitoring, including records of movements, corrective actions in case of unintentional errors, and communications received from the Ministry of the Interior.

13.-Procedure for spills and losses.

14.-Methodology of losses and gains; and,

15.-Internal audit procedure.

e) Implement systems for tracking the intake and expenditure of classified substances, recording the exact quantities used in intermediate products and finished goods, and supporting transactions with documentation that verifies their legal compliance.

f) Distribute to personnel responsible for activities related to substances subject to regulation the information provided by the Ministry of the Interior.

g) It provides the necessary facilities for control and inspection checks, and makes all information and documents related to the management of substances subject to regulation available to officials of the Ministry of Interior.

h) Review whether the substances used in your production or commercial processes are listed in the classification issued by the Ministry of the Interior. Also verify the composition of finished

chemical products containing one or more regulated substances with concentrations exceeding 85%, as well as aqueous dilutions of acids, bases, and oxidants with concentrations above 6N.

i) Control the facilities operated by the qualified person in which substances subject to supervision are handled, and implement industrial safety standards in those facilities.

j) Report to the Ministry of the Interior any suspicious or unusual activities involving substances

subject to monitoring.

k) Conduct internal audits to ensure the proper use of substances subject to regulatory oversight and to assess the company's current status regarding their movements.

l) Implement ongoing oversight to ensure compliance with technical and legal requirements in

managing substances subject to regulatory oversight, including monitoring available quotas to

prevent overuse, adhering to recommendations issued in inspection or regulatory reports, and other related aspects.

m) Conduct monthly physical inventories of substances subject to regulatory oversight and compare them with the accounting records.

n) Verify that the information reported to the SISALEM system corresponds to the actual transaction data of the regulated substances and is submitted within the specified timeframe.

o) Keep for two years the technical and legal documentation for the handling of substances classified as subject to supervision

p) Other duties of their position, mentioned or directed by the employer.

Job requirement:

1. Ecuadorian Nationality; Good spoken English;

2.Hold bachelor's degree or above. Medicine, biological correlation specialized first considered

1. At least two-three years' work experience;

2. Familiar with Ecuadorian laws and regulation procedure;

3. Have knowledge of medical device regulations in other South American countries