Senior Compliance and Approvals Regulatory Specialist

at  Dyson

SUMMARY

Salary:
Competitive
Team:
Design and Development
Location:
Singapore - St James Power Station Headquarters

ABOUT US

You will be a part of the Compliance and Approvals Team. We remove the barriers to accessing markets to make sure that Dyson products are met the regulations and standards. We are responsible for ensuring that all Dyson products comply with all relevant regulations, standards and legislation in over 90 countries. We use internationally recognised standards to demonstrate compliance as well as country or region-specific standards.

This role has regulatory affairs responsibilities include define regulatory compliance strategy, product submissions for New Product Development and Sustaining activities as assigned by the reporting manager. The role will require the oversight and management of legacy / New Product Introduction product registration projects such as license renewals, periodic updates and registrations to regulatory agencies, quality system compliance and audits, post market support (regulatory reporting), and continuous process improvement project involvement. You will work closely with cross-functional teams to prepare and submit regulatory documents, provide guidance on regulatory strategies, and monitor changes in regulations that impact our products.

• Develop and execute regulatory strategies to ensure compliance with applicable regulations and standards for medical products.
• Prepare and submit regulatory submissions, including 510(k) notifications, technical files, and other relevant documentation to regulatory authorities.
• Collaborate with cross-functional teams to gather necessary information and ensure timely completion of regulatory submissions.
• Conduct regulatory assessments to determine impact and compliance requirements for new product development and changes to existing products.
• Stay updated on current and emerging regulations, guidelines, and standards related to medical products and communicate changes to relevant stakeholders.
• Provide regulatory guidance and support to internal teams, including R&D, quality assurance, and marketing, to ensure compliance throughout the product lifecycle.
• Review changes to existing products and SOPs to define the requirements for regulatory submissions.
• Participate in regulatory agency inspections and audits, and assist in the preparation of responses and corrective actions as needed.
• Review and approve labeling and promotional materials to ensure compliance with regulatory requirements.
• Maintain regulatory documentation and records in accordance with regulatory guidelines.
• Oversee and maintain vigilance on regulatory issues and disseminate regulatory information to QA, R&D departments and senior management as required.