Regulatory Affairs & Quality Assurance Specialist (ASEAN)


Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities. If you are interested in working at one of the World’s Best Workplaces, apply now!

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

About the Role

In this regional role, you will be managing Regulatory Affairs & Quality Assurance (RAQA) activities and projects to comply with requirements of local authorities and Stryker corporate policies. Your impact will be to drive excellence and best practices for RAQA in the ASEAN region, with a focus in Malaysia. Your work will directly value add to Stryker's mission of making healthcare better.

What You Will Be Doing:
To be the primary local contact for Malaysia Regulatory Affairs activities
Manage product registrations/change notifications/re-registrations/license renewals/input requests questions in ASEAN region
Ensure timely initiation and closure of product registrations to be in line with product launches and business plans
Monitor the processes with regulatory authorities and Ministries of Health across the region to obtain regulatory approvals on time
Update, monitor and maintain data tracking, master records, monthly reporting and related documents
Ensure compliance to corporate policies and any local regulatory requirements
Participate in and support audit exercises such as internal audit, Indirect Channel audit and GDPMD
Support Post Market Activities and ensure timely and accurate reporting to authorities
Monitor and keep updated on changes in regulations related to pre-market/registration/post market surveillance requirements
Identify gaps and risks, and propose strategies to Management to mitigate such risks
Participate in local, regional and corporate initiatives and projects related to pre-market/post market activities
Lead, participate and coordinate projects related to RA and continuous process improvement across ASEAN region
Who We Are Looking For:
Bachelor's degree in pharmacy, biomedical sciences or other related fields
2 to 4 years of RAQA experiences in ASEAN countries, particularly in Malaysia
Regulatory knowledge on medical devices
Excellent communication skills and ability to manage internal and external stakeholders
Good negotiation and influencing capabilities
Strong planning and time management skills
Enjoys the autonomy of being an independent problem solver

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at  https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of  the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting  stryker.com
Posted
06/11/2022
Location
Petaling Jaya, 10, MY