Singapore QA and RA Executive

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.

Responsibilities:

• 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.

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