Senior Regulatory Affairs Specialist , SEA – Singapore
Convatec (Singapore) Pte Ltd
jobsDB ref: JSG400003002987828
The Senior Regulatory Affairs Specialist will support the South East Asia (SEA) geography in the Asia Pacific Region business concerning post market matters including product promotional activities, labeling review activities, product registration and listing database, global product registrations requests, export/import activities, and post market actions and associated activities. The incumbent will provide other regulatory support as assigned by their supervisor. Specific responsibilities of the role include, but are not limited to:
- Review and load new product listings, product delisting, registration of new manufacturing sites, etc into the registration and listing databases.
- Maintain renewals and up to date information for all registration and listings databases.
- Complete inquiries and requests from internal and external sources in regards to import/export processes and practices and US customs holds.
- Complete all training as required and maintain training plans, records, etc.
- Maintain the organization and the security for all regulatory paper and electronic files.
- Develop, write, implement and maintain RA SEA procedures.
- Report adverse events
- Complete regional RA requests and provide the requested documents i.e. CFG’s, LOA’s, documentation, etc.
- Review, comment and approve/disapprove change control requests which may affect the marketing of products.
- Complete a Letter to File following all regulations and guidance’s.
- Review and approve/disapprove labeling change request, advertising and promotional request, field communications, etc. in accordance with CVT standards and procedures and labeling regulations and guidance’s.
- Execute, manage and close post market activities i.e. recalls and corrections.
- Prepare and submit all reporting activities associated with a removal or correction with Authorities and Regional CVT RA team’s requirements.
- Keep informed about new and revised regulatory requirements.
- A minimum of a Bachelor’s degree in Science, Engineering, Medical Technology or Nurse required. An advanced degree and/or Regulatory Affairs Certification (RAC) is preferred
- 5 years of experience in regulatory affairs within medical device industry is preferred
- Understanding of the regulatory framework for medical devices in the region
- Understanding of the Quality System Regulations, recalls and correction and labeling requirements
- Experience with Class I, II, sterile and combination medical devices
- Familiarity with Class III, cosmetic or OTC products desirable
- Authored and implemented a minimum of 3 standard operating procedures
- Experience with UDI US requirements
- Executed or managed a post market action in the SEA
- Experience with FDA electronic submission is preferred (e.g., FURLS, Gateway, etc.)
- Experience with US submissions i.e. 510(k), IDE, PMA
- International Regulatory Affairs experience is desirable.
- Strong oral and written communication skills.
If you possess the skills and attributes listed above and want to make a difference in people’s lives, apply today and be rewarded with an attractive and competitive remuneration package.
To apply online, please click on the APPLY NOW.
Visit www.convatec.com for further information on our organization and products.
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About Convatec (Singapore) Pte Ltd
ConvaTec is a global medical products and technologies company, with leading market positions in wound therapeutics, ostomy care, continence and critical care, and infusion devices. Our products provide a range of clinical and economic benefits, including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care. We have over 8,000 employees, with 11 manufacturing sites in 8 countries, and we do business in more than 100 countries.
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