Salary Market Aligned
Location Kuala LumpurFULL_TIME
Consultant Sashi Lim
Job Ref P645EM-187AFF63
Date posted 26 May 2023kuala-lumpur healthcare-and-life-sciences/regulatory-affairs-and-quality-assurance 2023-05-26 2023-07-25 pharmaceuticals Kuala Lumpur MY Robert Walters https://www.robertwalters.com.my https://www.robertwalters.com.my/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true
An exciting RA Manager job has become available at a renowned medical device company here in Malaysia.
About the RA Manager Role:
Functionally and administratively reporting directly to the Managing Director, this role requires you to plan and execute strategic local regulatory approval obtainment for medical and safety devices for the assigned region.
- Manage new product registration, change notifications and renewal and ensure timeline submission and approval
- Handle authority communications (administrative and general technical) concerning regulatory submissions and liaise closely with the corporate regulatory affairs team and provide timely response to the authorities
- Provide regulatory pathway (RAR) to corporate regulatory affairs team based on local regulatory requirements
- Monitor and report the status of submissions, approvals and renewals to stakeholders
- Monitor and analyse new or revised regulations and the impact on business and communicate the impact to stakeholders
- Manage and maintain the integrated management system (ISO 9001, ISO 13485, and ISO 14001 and OHSAS 18001) and good distribution practice for medical devices (GDPMD) certifications
- Be the management representative for quality, environment, health and safety (Q-EHS) management system and GDPMD
- Collaborate with management, process owners and other colleagues in creation, maintenance and retention of policies, standards, working instructions, forms and other relevant system documentation
- Maintain and monitor required fault signalling and improvement systems for quality, occupational health and safety and environmental systems consistent with the related global processes: analyse and report to management on the effectiveness and efficiency of the integrated management systems
- Ensure implementation of field corrective actions, update and record status on field action record system
- Support in tracking, coordinating and consolidation of relevant QRA topics
- Support in the organisation of RA activities where necessary
- Any other ad hoc duties requested by RA Manager
To succeed in this RA Manager role, you will need to have the ability to work independently with minimal supervision.
- RA work experience in a medical device firm
- Preferably a background in Degree in Pharmacy and a registered pharmacist in Malaysia
- Experience handling approval topics for other related devices, e.g. safety products
- Experience in quality management system, e.g. ISO 13485/ISO 9001/ISO 14001/OHSAS 18001/GDPMD certification (this is not necessarily a mandatory requirement at the beginning, since this ability can be acquired by training and experience)
This multinational company needs someone who is very hands-on and driven to expand the company business. It is a very team-based environment for the work culture within the company. The firm is also very focused on growing employees internally.
If you are driven, determined and want to take the next step in your career, this is the role for you. Great career progression opportunities await the right person in this exciting RA Manager role.
Apply now to learn more or email at email@example.com.
Get in touch
+603 2303 7061
Salary: Market AlignedLocation: Kuala LumpurDate posted: 26 May 2023An exciting RA Manager job has become available at a world-renowned company here in Malaysia.