Regulatory Affairs Specialist

Regulatory Affairs Specialist Based In Kuala Lumpur

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 executing product registrations and ensuring regulatory compliance in Malaysia

What will you be doing?

• Ensure regulatory compliance in Malaysia.
• 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 FSCA to the regulatory authority.
• Review and report mandatory problem reporting (MPR) 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 stakeholders with regular updates throughout the registration process.
• Monitor changes in the regulatory environment in order to formulate appropriate company response to the changes.
• Review and submit promotional materials in accordance to the local advertising code and guidelines.
• Maintain regulatory databases or systems.
• Coordinate and review labelling translation and monitor the labelling approval process
• Support internal and external regulatory audit
• Coordinate and champion any regulatory projects

What will you need to be succesful?

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's degree in any engineering or science related discipline.
• At least 1-2 years RA working experience. Good to have 2-3 years RA working experience in a medical device company.
• Working knowledge, the regulatory controls of medical devices in Malaysia.
• Understanding of ‘Good Distribution Practice for Medical Devices’ certification.
• You. Unlimited.
• We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
• Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. 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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