Singapore QA and RA Executive
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Proclinical are recruiting for a Singapore QA and RA Executive to join a medical technology and devices organisation. This role is on a permanent basis and is located in Singapore.
- Handle the certificate of analysis issuance and quality management with contract manufacturers.
- Provide support for the new product registrations, renewals, and change notifications across Asia.
- Guarantee adherence to in-house quality standards and regulatory specifications.
- You will cooperate with health authorities and foreign agencies regarding regulatory concerns, licenses and permits.
- Responsible for preparing and preserving documentation for audits both internally and externally.
- Keep up to date on current and developing regulations, standards and guidance documentation.
- Evaluate product labelling, promotional resources and advertisements for regulatory compliance.
- Other duties may be assigned.
Key Skills and Requirements:
- Exhibited experience in QA or regulatory affairs within a medical organisation such as cosmetic, medical device, OTC drug, etc.
- Experience with GDPMDS, ISO13485, and GMP standards.
- Communication skills both verbally and in writing.
- An organised individual with a high attention to detail and the ability to manage own time efficiently.
- Computer literacy.
- Interpersonal capabilities with a positive mindset.
- A self-motivated individual who works well both in a team as well as independently.
If you are having difficulty in applying or if you have any questions, please contact Mandy Fang at +65 31582403.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.