Regulatory Affairs Specialist - Thailand
Regulatory Affairs Specialist - Thailand
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Job Description
With more than 10000 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. Convatecs revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).
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You will be responsible for the regulatory activities for all Convatec products including product registration (new renewal and amendment) product promotional activities labeling review activities product registration and listing database. The incumbent will provide other regulatory support as assigned by supervisor.
The responsible countries include Thailand and other South East Asia countries as assigned by supervisor.
Key duties and responsibilities:
Ensure regulatory compliance with local laws.
Prepare and submit documents to health authorities for product approvals.
Support regulatory strategy and update based on changes.
Handle post-approval activities and product lifecycle tasks (renewals changes listings).
Review and approve product changes labeling and promotional materials.
Communicate with health authorities to ensure timely approvals.
Participate in audits and support post market reporting.
Maintain regulatory databases and provide documents for reimbursement/tenders.
Stay updated on regulatory changes and inform relevant teams.
Collaborate with supply chain marketing and country manager on regulatory projects
Skills & Experience:
Bachelors degree in related field or higher; RAC certification is a plus.
Minimum 3 years in medical device regulatory affairs.
Experience with regulatory submissions and quality systems.
Knowledge of GDPMDS and ISO13485 preferred.
Strong communication skills in English
At Convatec were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.
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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 youre unsure please contact us at .
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!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
