changing lives.
The APAC Regulatory and Quality Assurance Department has a position in
Malaysiafor a Regulatory Affairs and Quality Assurance (RAQA) Specialist to support Malaysia RA, QA functions of the Department. The role is to oversee and focus on regulatory submissions, quality management system and post market efforts in Malaysia in achieving the department goals from a local level, cascading to APAC level. This Specialist role needs to provide oversight on the guidance and recommendations to country business stakeholders and exporting countries on Malaysia requirements and ensure compliance to acceptable local and Align practices. This position is also responsible for developing Malaysia regulatory strategies for local submissions and registrations, as well as QMS maintenance and post market compliance working in tandem with APAC and SEA RAQA for design input, regulatory and QMS assessments. Help to proactively drive Align’s agenda by engaging with Malaysia Health Authority and other applicable regulatory agencies and to ensure relationship building.
This position is based in Align’s Malaysia office and has a solid line reporting to the Director, Regulatory Affairs and Government Affairs, APAC, with a dotted line to the Director, Regulatory Affairs and Quality Assurance, APAC on QA and Post Market matters. The APAC corporate HQ is located in Singapore.
In this role, you will…
- Preparing and maintaining product registration dossiers complying with all registration requirements.
- Complete the relevant steps for product changes/renewals including communications with local authorities and reviewing regulations and guidelines.
- Conduct Post Market surveillance and reporting to authority, and the required follow up internally and externally.
- Review advertisements and related processes.
- Establish a working relationship with relevant authorities and industry associations.
- Act as Responsible Person for the establishment licence of Align Malaysia office
- Hold the role of Designated Person for Malaysia GDPMD and ensure maintenance and compliance of Align Malaysia GDPMD documents and implementing change management due to evolving local landscape and business requirements.
- Investigate and resolve quality issues, in a timely and effective manner including performing necessary authority reporting.
- Support the development and implementation of training programs to enhance awareness and understanding of quality and regulatory requirements across the organisation.
- Other duties as assigned.
- Support APAC RAGA Director on APAC RA administrative tasks.
In this role, you’ll need …
- Fluent in English and Malay writing, reading and communication skills.
- Must be able to work independently, and handle both small and large matters with equal effectiveness and enthusiasm.
- Ability to work independently and communicate effectively with cross-functional teams and external stakeholders.
- A strong commitment to excellence and high standards of integrity, professionalism, loyalty, honesty, respect, open mindedness, open communication, respect, and business ethics.
EDUCATION and/or EXPERIENCE
- Bachelor’s degree in science or engineering preferred.
- At least 6 years of experience in in quality assurance and regulatory affairs of Medical Devices in Malaysia.
- Experience in performing all regulatory functions (e.g., writing submissions, reviewing documentation for regulatory compliance, interfacing with regulatory agencies, etc.) for medical devices.
