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 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.
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.
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
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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