Job Description

Regulatory Affairs Specialist - 6 months contract based in Singapore
Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.
Achievement of territorial sales budget, profit and market share in line or exceeding company's objectives through execution of approved Sales and Marketing Plans and effective control of assigned territories.
What will you be doing?

• Ensure regulatory compliance in Singapore and the Export Markets.
• 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.
• 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.
• Report Field Safety Corrective Actions and Adverse Events to the Authority
• 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:

• 1-2 years RA working experience.
• Working knowledge the regulatory controls of medical devices in Singapore and Developing Markets.
• Bachelor degree in any engineering or science related discipline

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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