QUALIFICATIONS AND JOB DESCRIPTION

We are looking for dynamic, friendly, hard working, enthusiastic, resilient, talented and most importantly an idealistic candidates for 'Regulatory Affairs Specialist' role.

Job Description

• Implement and support registration and re-registration tasks with the authorities.
• Support the establishment and development of the RA sytem.
• Responsible for coordination and implementation of RA activities in line with international regulations, Chil Ltd. policies and procedures.
• Ensure the completion of regulatory certification/registration/notification/listing activities in a correct and timely manner.
• Evaluate the effects of change control activities from regulatory perspective and implement required regulatory steps on a timely manner.
• Follow the currency and delivery of quality documents and records to the third parties during registration activities.
• Follow-up of developments and changes in the local & international regulatory policy rules, legislations and guidelines with impact to Chil Ltd. activities. Analyze available regulatory and compliance information.

      We look forward to receiving your application. 

• Bachelor degree in Engineering or Science or Health/Life Sciences departments of universities. MSc, PhD is an assets.
• Preferably 2 to 3 years experience in Regulatory Affairs Management in a multinational environment (medical industry would be an asset).
• Working knowledge of regulatory registrations in local and international.
• Working knowledge with ISO 13485, MDD (93/42/EC), IVDD (98/79 EC), FDA requirements and the other global regulations.
• Good knowledge in MS Office software (Word, Excel, Powerpoint, Outlook) is required.
• Excellent command of written & spoken English is compulsory.
• Team player with excellent communication and presentation skills; able to develop collaborative relationships with various stakeholders and authorities both internal and external to achieve objectives.
• Analytical thinking, result and solution oriented, innovative, proactive, flexible and strong ability on problem solving and reporting. Must be able to identify creative options for resolving issues that respond to multiple stakeholder and authorities interests and needs,
• Strong and prompt planning, follow up, reporting, coordination and organization skills to achieve accurate and timely results.
• Be confident, positive, self-motivated& able to work independently
• Good communication skills
• Teamwork oriented, ability to establish and maintain effective working relationships
• Willing to learn, research and improvement

RESPONSIBILITIES & DUTIES

• Identify and secure reliable sources of quality goods from foreign and local suppliers, negotiating pricing, payment terms, and delivery cycles to meet the needs of the organization
• Assess foreign suppliers of goods, analysing performance and satisfaction in terms of pricing, supply, delivery, and quality
• Work closely with the regulation department to ensure contract terms are favourable to the company
• Develop and maintains relationships with prospective suppliers by discussing price, product quality, and delivery cycles
• Verify business and financial references of prospective suppliers
• Recommend potential suppliers to appropriate staff
• Coordinate trial orders with new suppliers
• Coordinate and expedite import process
• Oversee delivery dates, quality of production, and sufficiency of product
• Negotiate terms of payments with suppliers
• Identify and implement preferred payment methods
• Maintain current knowledge of external factors that could affect availability of goods and pricing; examples include applicable import regulations, taxes, tariffs, and political and economic situations in the countries of origin
• Review existing contracts with suppliers and vendors to ensure on-going feasibility
• Build and maintain long-term relationships with vendors and suppliers
• Perform other related duties as assigned
• Report to General Manager

SKILLS & COMPETENCIES

• Being familiar with the company’s supply process
• Strong understanding of procurement and negotiation techniques 
• Excellent verbal and written communication skills
• Strong negotiation and conflict resolution skills
• Able to travel to meet with suppliers and work overtime as required
• Fluency in English (speak, read and write)
• Have good knowledge of Microsoft Office 
• Have an outstanding communication skill, both verbally and in written form
• Have excellent organizational and planning skill for proper running of an organization 
• Be ambitious, have strong work ethic, and a willingness to learn 
• Be a fast learner with strong problem-solving skills 
• Positive & winning attitude 
• Ability to understand and effectively communicate at all management levels, technical dependencies, timeline impact and risks 
• Good attention to detail 
• Highly organized and detail oriented 

SUPERVISORY RESPONSIBILITIES                                       

No                                                                                                          

WORKING ENVIRONMENT

Office work environment. Regional travel 20%

REQUIREMENTS

• Bachelor’s degree in engineering, supply chain management, logistics, business administration or related fields
• In-depth knowledge of preparing and reviewing contracts, invoicing, and negotiation terms in foreign trade
• Basic understanding of the types of goods to be purchased

RESPONSIBILITIES & DUTIES

• Implement and maintain quality control system in accordance with applicable regulatory requirements
• Manage, initiate, and participate in resolution of customer complaints and non-conforming material
• Responsible for final product release sign-off
• Oversees quality needs for the quality control team
• Assist and/or manage plant projects and drive to completion
• Participate in audits as process and quality systems
• Develop root cause investigations CAPA experience
• Develop an understanding of the validation system and assist in validations.
• Conduct diagnostic and statistical analysis of methods, equipment, and materials to improve product quality, process reliability and cost
• Assist in meeting plant team plans for cost and quality improvement, operating within department budget guidelines
• Demonstrate ability to make consistent and data driven decisions
• Inspect incoming, in-process, finished parts, and materials for conformance to quality control standards
• Reports to Quality Assurance Executive

SKILLS & COMPETENCIES

* Become an authority in application of statistical tools, measurement systems analysis, and root cause analysis, and system validations * Take ownership of projects and drive to completion, whether working independently or in a team * Will work cross-functionally with suppliers and customers in project management and problem-solving activities * Ability to speak, read and write English * Have good knowledge of Microsoft Office * Have an outstanding communication skill, both verbally and in written form * Have excellent organizational and planning skill for proper running of an organization * Be ambitious, have strong work ethic, and a willingness to learn *Be a fast learner with strong problem-solving skills * Positive & winning attitude * Ability to understand and effectively communicate at all management levels, technical dependencies, timeline impact and risks * Good attention to detail * Good eye for design * Creative and technical ability to turn designs into products *

SUPERVISORY RESPONSIBILITIES                                       

10+ quality inspectors 

WORKING ENVIRONMENT

Office work environment. Regional travel 20%.

REQUIREMENTS

• Bachelor’s degree in biomedical, genetics, biochemistry, and related fields
• Several years of professional experience in quality management and/or manufacturing
• Experience at a Pharma, Biotech, or Medical Device manufacturer preferred

RESPONSIBILITIES & DUTIES

• Manage the cross functional relations to make sure the quality assurance system run continuously and effectively
• Ensure to comply overall quality assurance system in CHIL by keeping up to date
• Devise and establish CHIL’s quality procedures, standards, and specifications
• Involve producing quality documentation, maintaining quality management systems, carrying out product quality reviews and performing audits to ensure that all devices comply with regulatory requirements
• Direct and oversee the documentation process
• Review customer requirements and make sure they are met
• Work with purchasing staff to establish quality requirements from external suppliers
• Set standards for quality, as well as health and safety issues
• Serve as the Management Representative and ensure all relevant processes meet national and international standards
• Establish and maintain controls and documentation procedures
• Maintain quality system in compliance with all applicable regulatory standards (FDA, WHO, ISO 13485, ISO 9001, GMP) and other relevant requirements throughout the company
• Make sure the company is working as effective as possible to keep up with competitors
• Specify quality requirements of raw materials with suppliers
• Work with operating staff to establish procedures, standards, and systems
• Always direct objectives to maximize profitability
• Train production staff on quality procedures, protocols, and documentation
• Reports to General Manager

SKILLS & COMPETENCIES

* Become an authority in application of statistical tools, measurement systems analysis, and root cause analysis, and system validations * Take ownership of projects and drive to completion, whether working independently or in a team * Will work cross-functionally with suppliers and customers in project management and problem-solving activities * Ability to speak, read and write English * Have good knowledge of Microsoft Office * Have an outstanding communication skill, both verbally and in written form * Have excellent organizational and planning skill for proper running of an organization * Be ambitious, have strong work ethic, and a willingness to learn * Be a fast learner with strong problem-solving skills * Positive & winning attitude * Ability to understand and effectively communicate at all management levels, technical dependencies, timeline impact and risks *

SUPERVISORY RESPONSIBILITIES                                          

10+ engineer and quality inspectors

WORKING ENVIRONMENT

Office work environment. Regional travel 20%

REQUIREMENTS

• Bachelor’s degree in engineering, science, or related fields
• Several years of professional experience in quality management