Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

 

Position Summary:

Be the Management representative for Convatec Korea. Establish, implement, and maintain the appropriate procedure related to local regulatory requirements and ensure compliance to the requirements. Work closely with RA to compile, prepare, review and submit regulatory (KGMP) submissions to the local health authorities. Execute QA activities with internal Convatec counterparts such as Sales, Marketing, Supply Chain partners and distributors as appropriate. Overseeing local Labeling Process and control. Ensure the label approved by RA which is updated to label master file is implemented at the distribution warehouse.

Key Responsibilities

• Management Representative for Convatec Korea. Review and manage the development, writing, implementation and maintenance of appropriate procedures, templates, metrics, and databases related to regulatory activities and ensure documentation is in compliance with the local regulatory requirements.

• Work with different functions to implement established processes. Ensure company business operation comply with requirements.

• Compile, prepare, review and submit regulatory (KGMP) renewal applications to the local health authorities.  Identify potential issues early in the submission preparation process and work closely with QA Director to overcome the issue. Accompany the auditor to perform on site KGMP audit at the manufacturing/ registered sites if needed

• Maintain and timely update of registration status for the manufacturing sites into the relevant registration and listing databases. 

• Reporting to top management on the effectiveness of the quality management system and the need for improvement.

• Ensure that awareness of applicable regulatory requirements and quality management system requirements is enhanced throughout the organization. Keep abreast of new and updated regulatory requirements and communicate the changes to the relevant stakeholders as necessary. 

• Support any quality aspects relating to distribution chains. Execute QA activities with internal Convatec counterparts, logistics partners and distributors as appropriate.

• Overseeing local Labeling Process and control. Ensure the label approved by RA which is updated to label master file is implemented at the distribution warehouse.

• Report non-conformity or defects based on the input information provided by the distribution warehouse. Coordinate the stop ship activities with local distribution centers.

• Coordinate the re-inspection according to the protocol or procedure issued by the manufacturing site and report back the inspection results timely.

• Manage customer complaint handling process, including the reporting and follow up with distributor in Korea.

• Execute, manage, and close post market activities for example recalls and corrections.  Responsible to consolidate the response form, reconciliation of recall quantity, prepare and submit all reporting activities associated with a removal or correction with the local health authorities and ConvaTec Global Compliance Team.

• Ensure GxP suppliers are qualified as required in according to Global procedure, to assist in the audit if necessary, in order to support the supplier qualification process.

• Complete all training as required and maintain training plans, records, etc

• Support as requested by line manager with all other requests for information and documentation associated with quality assurance.

Requirement

• Preferably 5 years' experience in post-market quality assurance (QA) in medical device / pharmaceutical industry

• Bachelor’s degree in science, Engineering, or Medical Technology is required

• Experience in Quality Management Systems, such as ISO-13485:2016, Korean GMP requirements is required.

• English communication skill in verbal and written.

• Strong communication and project management skills, ability to multi-task and deliver within tight timelines.

 

 

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at [email protected].

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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