Regulatory Affairs – Singapore

Resourcing Life Science; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A leading company in the life sciences sector is looking for a Regulatory Affairs Specialist to oversee regulatory submissions across global markets. The role involves engaging with regulatory authorities, preparing applications, and maintaining compliance with EU MDR regulations. The ideal candidate will have at least 5 years of experience and be fluent in English.

Qualifications

• Minimum 5 years of experience in Regulatory Affairs.
• Fluent in English.

Responsibilities

• Manage regulatory submission timelines for new and existing products.
• Prepare and file global medical device applications.
• Engage with regulatory authorities for product registrations.

Skills

Fluent English

Job description

What to Expect

• Establish and manage regulatory submission timelinesfor both new and existing products across key global markets
• Prepare and file global medical device applications and amendments, ensuring timely market access.
• Engage with regulatory authorities and distribution partnersto support product registrations
• Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
• Conduct global regulatory impact assessmentsfor product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directivesto ensure ongoing global compliance.
• Review and approve product labelingto ensure compliance with global regulatory requirements.
• Support and participate in inspections and auditsconducted by global regulatory authorities.

Requirements

• Minimum 5 years of Experience
• Fluent English

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or [e-mail]

Tagged as: Regulatory Affair