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.
About the role
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.
About you
B.S. Degree in Science and Engineering field with at least 5 years relevant experience within the regulatory affairs discipline
Experience with Class I and Class II devices is a plus
Regulatory Affairs Certification desired, international experience is a plus
Ability to define problems, analyze data, establish facts and draw conclusions
Working knowledge of US and international medical device regulatory requirements
Solid understanding of medical device regulations, including FDA 21 CFR Part 820 and ISO 13485.
Experience New / Existing Product Development that includes product registrations with the regulatory agencies
Active within regulatory associations and forums with great networking capabilities with fellow industry colleagues is preferred
Excellent analytical decision making and problem-solving skills
Excellent written and verbal communication skills, with the ability to communicate complex regulatory information clearly and concisely.
Good interpersonal, analytical and organizational skills
Benefits
Dyson Singapore monitors the market to ensure competitive salaries and bonuses. Beyond that, you’ll enjoy a transport allowance and comprehensive medical care and insurance. But financial benefits are just the start of a Dyson career. Professional growth, leadership development and new opportunities abound, driven by regular reviews and dynamic workshops. And with a vibrant culture, the latest devices and a relaxed dress code reflecting our engineering spirit, it’s an exciting team environment geared to fuelling and realising ambition.
Dyson is an equal opportunity employer. We know that great minds don’t think alike, and it takes all kinds of minds to make our technology so unique. We welcome applications from all backgrounds and employment decisions are made without regard to race, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other any other dimension of diversity.
