Regulatory Affairs

Resourcing Life Science; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A global regulatory consultancy in Singapore is seeking an experienced regulatory affairs specialist to manage submissions and ensure compliance with international standards. The ideal candidate has over 5 years of experience, is fluent in English, and will collaborate with cross-functional teams to integrate regulatory requirements throughout the product lifecycle. A competitive salary and support with market access are provided.

Qualifications

• Minimum 5 years of experience in regulatory affairs.
• Fluent in English.

Responsibilities

• Establish and manage regulatory submission timelines.
• Prepare and file global medical device applications.
• Engage with regulatory authorities for product registrations.
• Maintain EU MDR-compliant technical documentation.
• Conduct global regulatory impact assessments.

Skills

Regulatory submission management

Technical documentation compliance

Global regulatory standards interpretation

Cross-functional team collaboration

Product registration support

Job description

What to Expect

• Establish and manage regulatory submission timelines for 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 partners to 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 assessments for 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 directives to ensure ongoing global compliance.
• Review and approve product labeling to ensure compliance with global regulatory requirements.
• Support and participate in inspections and audits conducted 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 email [e-mail]

Tagged as: Regulatory Affair