Medical Affairs Professional
3 days ago
Company Overview
B. Braun Melsungen AG is a leading medical technology company with over 66,000 employees in 64 countries. Founded in Germany in 1839, we specialize in infusion therapy, orthopaedics, neurosurgery, anaesthesia, and more.
In Asia Pacific, B. Braun employs over 16,000 people across 10 production sites and 16 business offices. Established in 1972, our regional headquarters for APAC is located in Penang, Malaysia.
Sector Overview
We develop high-quality products and services that improve global health. Our portfolio includes medical, surgical and pharmaceutical products, as well as intravenous access solutions.
Your Role
As an Executive/ Sr. Executive - Regulatory Affairs, you will play a vital role in ensuring compliance with regulatory requirements and maintaining product quality standards.
Your Responsibilities
- Prepare applications for permits, licences, certificates, authorisations, and other approvals necessary for conducting business activities.
- Document and maintain product dossiers, certification applications, and filings required to operate.
- Communicate regularly with federal regulators and ensure company policies strictly adhere to statutory requirements.
- Assist the area in relation to processes of product qualification and certification with government regulatory agencies.
Your Qualifications
- Degree in science or related field.
- More than 3 years experience as regulatory affairs in medical industries.
- Proficiency in both written and verbal English language.
- It will be an advantage if you have experience in regulatory affairs beyond Malaysia or from the pharmaceutical industry and experience in Quality Management and GDPMD.
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