Senior / Regulatory Affairs Executive

Ambu Sdn. Bhd.; Bayan Lepas; On-site; MYR 48,000 - 72,000; Full time

Job summary

A leading company in the field of medical devices seeks a Regulatory Affairs Executive to oversee product registration and compliance. The ideal candidate will possess a degree in Science or Engineering and bring at least three years of experience in regulatory affairs, ensuring all documentation is accurately prepared for submission. You will work closely with project teams and support marketing initiatives while being part of a dynamic and international work environment.

Benefits

Professional development opportunities

Dynamic and international workplace

Commitment to a positive working environment

Qualifications

• Minimum 3 years' working experience in Regulatory Affairs.
• Knowledge of regulatory and registration document submission.

Responsibilities

• Prepare product technical documentation and registration documents.
• Advise project teams on regulatory aspects.
• Support marketing on label changes.

Skills

Knowledge of ISO 13485

Commitment

Positive attitude

Flexibility

Team spirit

Education

Degree in Science or Engineering

Job description

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Involve in Innovation projects - Advise project team on regulatory aspects and changes that would affect product manufactured.

Prepare product technical documentation.

Involve in product registration - Prepare product registration documents for the requested countries, work with regulatory body/ agency on required document for registration submission.

To apply Free Sale Certificate & Manufacturing Certificate and arrange for legalization of certificates.

Work with HQ on regulatory documents and release order.

Support marketing on label changes and marketing material review.

Other regulatory task as assigned.

Requirements:

Degree in Science or Engineering.

Preferable with minimum 3 year's working experience in Regulatory Affairs.

Knowledge of ISO 13485.

Knowledge of regulatory and registration document submission in ROW.

Personal - Committed with positive attitude, flexible, good accountability and good team spirit.

What can Ambu offer you?

Ambu is experiencing a very positive and exciting development. We are a dynamic and international workplace with skilled colleagues who emphasize freedom with responsibility and to have a good working environment.

Ambu’s ambitious growth objectives means that there is a natural focus on the ongoing development of your professional and personal skills that will help to ensure our continued success.

We offer a wide range of professional, social and economic benefits, in addition to the exciting challenges of the job, which adds to your job satisfaction.

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Salary match Number of applicants Skills match

Your application will include the following questions:

What's your expected monthly basic salary? How many years' experience do you have as a Regulatory Affairs Executive? How much notice are you required to give your current employer?

About Ambu

Since 1937, breakthrough ideas have driven our work to bring efficient healthcare solutions to life within our fields of excellence: Anaesthesia, Patient Monitoring & Diagnostics and Emergency Care. Millions of patients and healthcare professionals worldwide depend and rely on the functionality and performance of our products.

We are dedicated to improving patient safety and determined to advance single-use devices.

The manifestations of our efforts range from early inventions like the Ambu Bag resuscitator and the legendary BlueSensor electrodes to our latest landmark solutions such as the aScope endoscope – the world’s first single-use flexible video scope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognised medico-technical companies in the world.

Our head office is situated near Copenhagen in Denmark. Ambu employs approximately 4,200 people in Europe, North America, and the Asia Pacific.

For more information, please visit www.ambu.com.

About Ambu

Since 1937, breakthrough ideas have driven our work to bring efficient healthcare solutions to life within our fields of excellence: Anaesthesia, Patient Monitoring & Diagnostics and Emergency Care. Millions of patients and healthcare professionals worldwide depend and rely on the functionality and performance of our products.

We are dedicated to improving patient safety and determined to advance single-use devices.

The manifestations of our efforts range from early inventions like the Ambu Bag resuscitator and the legendary BlueSensor electrodes to our latest landmark solutions such as the aScope endoscope – the world’s first single-use flexible video scope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognised medico-technical companies in the world.

Our head office is situated near Copenhagen in Denmark. Ambu employs approximately 4,200 people in Europe, North America, and the Asia Pacific.

For more information, please visit www.ambu.com.

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What can I earn as a Regulatory Affairs Executive