Regulatory Affairs Specialist

Smith+Nephew (Thailand) (Bangkok, Bangkok City, Thailand)

Bangkok, Thailand

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude, we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.

About this position

Regulatory Affairs Specialist based in Bangkok responsible for ensuring market access and regulatory compliance in Thailand by completing product registrations.

Responsibilities

• Ensure regulatory compliance in Thailand.
• Compile registration dossiers for new product registrations or change notifications according to regulatory plan and local regulatory requirements.
• Submit product registrations or change notifications to the relevant regulatory authorities and acquire approval timely.
• Monitor, manage, submit license renewals timely.
• Report AE, DD, FSCA, Medical device annual report to the regulatory authority.
• Assess impact of changes initiated by Product Owner and work closely with the supply chain, manufacturing and commercial teams to ensure no disruption to supply.
• Provide internal collaborators with regular updates throughout the registration process.
• Monitor changes in the regulatory environment in order to formulate appropriate company response to the changes including communicate changes to internal collaborators.
• Review and manage submission to the regulatory authority for promotional materials in accordance with the local advertising code and guidelines.
• Manage and maintain e-IFU. Communicate, coordinate with marketing and QA for local labelling.
• Maintain regulatory databases or systems.

Requirements

• Bachelor degree in any science, pharmacy or engineering related discipline.
• Minimum 3-5 years RA working experience in a medical device industry.
• Working knowledge the regulatory controls of medical devices in Thailand.
• Excellent verbal and written communication skills.
• Demonstrated resilience working under pressure and to tight deadlines.
• Highly effective interpersonal skills and the ability to build relationships with internal and external customers.
• Able to multi-task.
• Analytical, critical thinking and problem solving.