Executive/ Sr. Executive - Regulatory AffairsPrepare 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.
Job Requirements
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.
It will be an advantage if you experience in Quality Management and GDPMD.
B. Braun Medical Industries Sdn Bhd (BMI) is a subsidiary of B. Braun Melsungen AG, Germany, one of the largest medical devices companies in the world. Established in 1972, B. Braun Medical Industries in Penang is the group's first manufacturing site in Asia Pacific Region and it is one of the largest B. Braun manufacturing sites for the group outside Europe.
Since its inception in 1972, B. Braun Medical Industries has invested more than MYR4.3 billion in its manufacturing facilities in Malaysia. With more than 7,500 employees, the plant located in Penang is among the largest manufacturers of Medical and Pharmaceutical products not only in Malaysia but also in the region.
Are you looking for a challenge within a dynamic global organisation or a German family business? At B. Braun you can find both. For more than 180 years and counting, B. Braun is amongst the world's top healthcare companies operating in 64 countries, with over 60,000 experts networking their knowledge every day. You can thrive in this strong culture of continuous exchange. Become a part of the B. Braun family and share your expertise. Together we improve healthcare.#J-18808-Ljbffr