raqa specialist in Singapore

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job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
salary
s$ 40,000 - s$ 60,000 per year
experience
3 years
reference number
91M0125697_1536895035
contact
johari masod, randstad
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job description

about the company

A leading European medical device manufacturer with over 6000 employees worldwide. Apart from providing application systems for human and animal medicine, the company is also renowned for industrial application systems. There are looking for RAQA Executive to support their operations in the region

about the job

The RA Executive will be involved in coordinating and documenting regulatory processes, such as inspections, license renewals or registrations and ensuring all products are in compliance with local regulations.

Prepare and submit quality regulatory dossiers, applications, reports and notifications to the relevant regulatory bodies in a timely manner according to regulatory and company requirements.

Ensure timely post-market surveillance reporting until closure (complaints, adverse events, CAPA, FSCA, recalls).

Ensure products imported and supplied comply with local regulations.

Prepare and provide support for external FDA Audit.

about the manager/team

Reporting to the RAQA Manager, you will be a sole contributor, collaborating with other departments to ensure timely progress of the submissions and approvals


skills & experience required

You must possess a recognized diploma/degree with at least 3 years of experience in regulatory affairs for the medical device industry.

Knowledge or experience in liaising with regulatory bodies in the South East Asia countries is a must and interactions the Philippines FDA a strong advantage.

You can expect regional travel up of up to 20%.


To apply online, please click on the appropriate link. Alternatively, please contact Johari Masod on +65 6510 3651 quoting Ref No. 90M0334988

EA: 94C3609 / R1109554



skills

Regulatory Affairs, medical devices

qualification

no additional qualifications required

educational requirements

Bachelor Degree