Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.
The role is responsible to ensure market access and market continuity by completing product registrations and ensuring regulatory compliance in Thailand.
What will you be doing?
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 obtain approval timely.
Submit license renewals timely.
Report Field Safety Corrective Actions, Adverse Events and medical device annual reports to the 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 stakeholders with regular updates throughout the registration process.
Review and manage submission to the regulatory authority for promotional materials in accordance with the local advertising code and guidelines.
Maintain regulatory databases or systems.
Maintain Thai IFU and upload it onto the website.
What will you need to be successful?
Success in the role will require a combination of technical knowledge, soft skills, and a deep understanding of both the business and service-providing sides of an organization. Successful candidates would need the following:
Bachelor degree in any science, pharmacy or engineering related discipline.
1-2 years RA working experience.
Working knowledge the regulatory controls of medical devices in Thailand.
Excellent verbal and written communication skills.
You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website (https://www.smith-nephew.com/)
Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options.
Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.
Flexibility: Hybrid Working Model (For most professional roles).
Training: Hands-On, Team-Customised, Mentorship.
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