Job Information
ConvaTec Regulatory Affairs Manager in Seoul, South Korea
About Convatec
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 more than 10,000 colleagues, we provide our products and services in around 90 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. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com
Our search for better is changing the lives of our patients. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We're looking for a motivated and passionate individual to join our team as Regulatory Affairs Manager , to have real impact and bring Forever Caring to life.
About Role
In this role, you'll play a key part in working alongside a dynamic team that values innovation, collaboration, and continuous growth.
Your key responsibilities will include:
Develop regulatory strategy and update the strategy based upon regulatory changes and business needs
Manage and execute regulatory compliance activities as required by the local regulations
Compile, prepare,reviewandsubmitregulatory submissions to the local health authorities as well as toidentifyissues early in the submission preparation process that couldimpactproduct launch
Monitor andsubmitapplicable reports and appropriate responses to the local health authorities
Review and manage the development, writing, implementation and maintenance ofappropriate procedures, templates, metrics, and databases related to regulatory activities and documentation in compliance with the local regulatory requirements
Interact with local health authorities during review process to ensuretimelyregulatory approval
Ensure compliance with product post marketing approval conditions
Manage product lifecycle maintenance such as product license renewal, listings, change control notifications, etc.
Complete all training asrequiredandmaintaintraining plans, records, etc.
Review product labeling for approval in advertising and promotional request, field communications, etc.in accordance withConvaTecstandards and procedures as well as the local regulations
Support and/orparticipateas necessary in quality compliance audits
Maintain the organization and security for all regulatory paper and electronic files
Provide support in product safety issues and product associated events and responsible for reporting to the local health authorities
Asappropriate, provide content for local labellingin accordance withlocal regulation and registration approval and work with relevant parties to release andmaintainthe local labelling
Prepare andsubmitall reporting activities associated with a removal or correction with the local health authorities andConvaTecGlobal Compliance Team
Maintaintimelyupdates of new product listing, product delisting, registration of new manufacturing sites, etc. into the relevant registration and listing databases. Support to commercial team in providing regulatory documents required for reimbursement and tender applications
Communicate regulatory issues that mayimpactthe marketing of the products to internal stakeholders
Work in close collaboration with key functions such as supply chain,marketingand countrybusiness unitmanagersfor regulatory project / change implementation
May be tasked to act as the company focal point for interaction with various government agencies in response to queries from the agencies
About You
To be successful you will:
Bachelor/master's degree in science, MedicalTechnologyor related disciplines. Regulatory Affairs Certification (RAC) is preferred.
Minimum 5 years of experience in medical device regulatory affairs is necessary
Related experience and knowledge in regulatory submissions to local authorityrequired
Related experience and knowledge in Quality Management System, including but not limited to recalls, correction and labeling requirements isadvantageous
Experience in Good Distribution Practice for Medical Devices (GDPMDS) requirements and ISO13485 isadvantageous
Education/Qualifications
Minimumeducational requirements if applicable (for example Degree, industry qualifications,etc)
Industry memberships / Professional Registrations
What You’ll Get
At Convatec we believe in taking care of our people, because they’re the heart of everything we do . As part of our team, you’ll enjoy a range of benefits designed to support your wellbeing, growth, and success.
These include
Flexible working arrangements,
Ongoing learning and development opportunities
Competitiveremuneration
Access to health and wellbeing programs
Ready to join us?
At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
#LI-EZ1
#LI-Onsite
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 careers@Convatec.com .
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.
Already a Convatec employee?
If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!