Senior Regulatory Affairs Specialist

Smith & Nephew; Singapore; Hybrid; SGD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Regulatory Affairs Specialist to ensure market access and compliance for medical devices in Singapore and Export Markets. This role requires a blend of technical expertise and soft skills, with responsibilities including compiling registration dossiers, submitting to authorities, and maintaining regulatory databases. The company promotes a culture of inclusion and diversity, offering a hybrid working model, generous bonuses, and comprehensive health plans. If you are passionate about regulatory affairs and want to make a significant impact in the medical device sector, this opportunity is for you.

Benefits

Generous annual bonus

Pension schemes

Share options

Flexible vacations

Paid holidays

Volunteering hours

Private health plans

Dental plans

Income protection

Life assurance

Qualifications

• 5+ years of experience in Regulatory Affairs in the medical device industry.
• Detailed knowledge of medical device regulations in Singapore and Export Markets.

Responsibilities

• Ensure regulatory compliance in Singapore and Export Markets.
• Compile and submit registration dossiers to relevant authorities.
• Provide regulatory guidance and mentorship to junior colleagues.

Skills

Regulatory Affairs

Medical Device Regulations

Technical Expertise

Communication Skills

Education

Bachelor's Degree in Engineering

Bachelor's Degree in Science

Job description

Senior Regulatory Affairs Specialist

Apply locations: SGP - Singapore | Time type: Full time | Posted on: Posted Yesterday | Job requisition id: R82006

Senior Regulatory Affairs Specialist based in Singapore

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

As a Senior Regulatory Affairs Specialist, you will work independently with limited supervision to ensure market access and continuity by executing product registrations and maintaining regulatory compliance in Singapore and Export Markets.

What will you be doing?

• Ensure regulatory compliance in Singapore and Export Markets
• Compile registration dossiers for new product registrations or change notifications according to regulatory plans and local requirements
• Submit registration dossiers or change notifications to relevant authorities and obtain approvals promptly
• Ensure timely submission of license renewals
• Report Field Safety Corrective Actions and Adverse Events to authorities
• Assess impact of changes initiated by Product Owner and collaborate with supply chain, manufacturing, and commercial teams to prevent disruptions
• Provide regular updates to internal stakeholders during registration processes
• Review promotional materials in accordance with local advertising standards
• Maintain regulatory databases and systems
• Develop regulatory strategies for new product development projects
• Stay updated on applicable laws, regulations, and standards; interpret and assess impacts of regulatory changes
• Provide regulatory guidance and mentorship to junior colleagues

What will you need to be successful?

Success requires a blend of technical expertise, soft skills, and a deep understanding of business and service aspects. The following are essential:

• Bachelor's degree in engineering or science-related discipline
• At least 5 years of Regulatory Affairs experience in the medical device industry
• Detailed knowledge of medical device regulations in Singapore and Export Markets

You. Unlimited.

We believe in creating the greatest good for society. Our investments focus on our people and the patients we serve.

• Inclusion, Diversity, and Equity: Committed to welcoming and celebrating diversity. Learn more about our Employee Inclusion Groups on our website.
• Your Future: Generous annual bonus, pension schemes, and share options.
• Work/Life Balance: Flexible vacations, paid holidays, and volunteering hours to give back to communities.
• Your Wellbeing: Private health and dental plans, healthcare cash plans, income protection, and life assurance.
• Flexibility: Hybrid working model for most professional roles.
• Training: Hands-on, team-customized mentorship programs.

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