Executive/ Sr. Executive - Regulatory Affairs
You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Are you passionate to be in the role as Executive/ Sr. Executive - Regulatory Affairs? Do you have experience in Regulatory Affairs in medicla device ? If so, this opportunity could be for you! Join us at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!
As a Executive/ Sr. Executive - Regulatory Affair at B. Braun you will play a vital role in…
Your key responsibilities:
- Prepare applications for the permits, licences, certificates, authorisations, and other approvals that the organisation needs to conduct its business activities; and produce, sell, and distribute its goods and services.
- These may include product licences, manufacturing, import and export permits. Prepare and coordinate registration and development of trademarks for the organisation's range of products.
- Document and maintain the product dossiers, certification applications and filings required to operate.
- Communicate regularly with federal regulators and ensure company policies strictly adhere to statutory requirements.
- Prepare management reports and rate filings and make recommendations for new rate schedules.
- Assist the area in relation to processes of product qualification and certification with government regulatory agencies.
What you will bring to the team:
- 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 experience regulatory affairs beyond Malaysia or from the pharmaceutical industry and experience in Quality Management and GDPMD.
What sets B. Braun apart?
Founded in Germany in 1839, B. Braun is a leading medical technology company with over 66,000 employees in 64 countries. Specializing in infusion therapy, orthopaedics, neurosurgery, anaesthesia, and more, B. Braun develops high-quality products and services that improve global health. In Asia Pacific, B. Braun employs over 16,000 people across 10 production sites and 16 business offices.
Established in 1972, B. Braun Medical Industries in Penang is the regional headquarters for APAC. With more than 7,000 employees, the plant located in Penang is among the largest manufacturers of medical, surgical and pharmaceutical products not only in Malaysia but also in the APAC region. It also houses the Centre of Excellence for Intravenous Access.
What can we offer you?
- Retirement benefit scheme
- Long service award
- Medical insurance
- Training and development programs
- Education assistance program
What’s next?
Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the interview. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary!
We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are.
To find out more about our commitment to diversity click here
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B. Braun Medical Ind. Sdn. Bhd. |Sheryn | [email protected]