About the Company
The client is a prominent player in the medical device industry across Asia. They are a well-established organization known for their commitment to innovation and quality, providing essential medical solutions that improve patient care. The company fosters a collaborative environment and is dedicated to maintaining the highest standards of regulatory compliance and product excellence.
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About the Team | Manager
This role reports directly to the RA Manager and is a key part of the team responsible for ensuring product compliance and quality across various markets. You will work closely with internal teams, including factories and headquarters, as well as external regulatory bodies to achieve business objectives.
About the Job
As a Regulatory Affairs Specialist, you will manage all aspects of quality and regulatory compliance for medical devices. Your responsibilities include spearheading product registration, acting as the main point of contact for regulatory teams, and providing expert advice on standards and regulations. You'll also handle post-market surveillance, manage adverse events and recalls, and participate in both internal and external audits.
Skills and Experience Required
- A minimum of 2 years of experience in Regulatory Affairs within the medical device industry.
- Proven ability to coordinate and manage product registration processes.
- Experience in providing regulatory advice and interpreting guidance documents.
- A solid understanding of quality management systems, complaint handling, and post-market surveillance activities.
- Experience in conducting or participating in audits is highly preferred.
- Strong communication and interpersonal skills, with the ability to liaise effectively with various stakeholders, including local authorities.
- A proactive and meticulous approach to work, with a strong focus on compliance and quality.
If you are a dedicated professional with a background in Regulatory Affairs for medical devices and are looking to make a significant impact in a key regional role, we encourage you to apply.
To apply online, please use the 'apply' function. You may contact Putra Nur Afiq (EA: 94C3609/R22105891) directly via email or LinkedIn for more information. We regret to inform you that only shortlisted candidates will be notified.
