Regulatory Affairs Specialist I

This position is responsible for Regulatory Affairs support of ongoing regulatory compliance throughout the product lifecycle. The successful candidate is expected to demonstrate their commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and understanding of the regulations governing the quality systems. The position is also responsible for ensuring continued compliance with regulatory agency approvals including supplier/design and process change impact assessments. Role will potentially require some International travel. Opportunities to work with teams based in EU and US.

Job Responsibilities:

• Review and assessment of product and manufacturing changes for compliance with applicable regulations.
• Collaboration with international regulatory counterparts to provide deliverables and ensure compliance to local regulations when developing regulatory strategies and assessing changes.
• Support in Regulatory body audits, such as FDA, BSI, DEKRA.
• Liaise with both middle and senior management on any regulatory issues relating to their area.
• Maintain information in any internal regulatory databases.
• Support and maintain Quality initiatives in accordance with BSC Quality Policy.
• Continuously assess ways to improve Quality.

Job Requirements:

• Candidate requires at least a Bachelor’s degree in a scientific, technical or related discipline.
• Minimum of one (1) year Regulatory Affairs or related experience in the Medical Device industry.
• Has general knowledge of current and proposed US and EU regulations for medical devices.
• Familiar with ISO 13485 and MDSAP requirements.
• Ability to manage several projects simultaneously with keen attention to detail.
• Ability to review, collate, describe, and summarize scientific and technical data.
• Effective research and analytical skills.
• Effective written, oral communication, technical writing and editing skills.
• Ability to work independently with minimal supervision.
• Team player with good interpersonal skills.
• General knowledge of product development process and design control.
• Proficiency in the use of computer programs, particularly Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat.

Your application will include the following questions:

• Which of the following Microsoft Office products are you experienced with?
• How many years' experience do you have as a Regulatory Affairs Specialist?
• Which of the following types of qualifications do you have?
• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• Do you have a Bachelor Degree?