Quality & Regulatory Affairs Consultant at UL Solutions

Kuala Lumpur, , Malaysia -

Full Time

Start Date

Immediate

Expiry Date

05 Oct, 26

Salary

0.0

Posted On

07 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Device Registration, Regulatory Affairs, Quality Assurance, Gap Analysis, Regulatory Reporting, Client Consultation, Product Labeling, Audit Response, Microsoft Office, Project Management, Technical Writing, Research

Industry

Professional Services

Description

* Assist consulting team and clients with the preparation and submission of medical device registration/licensing applications to a single or specific number of regulatory markets. * Prepare renewals or amendments to the above, and act as support to a project team lead (project manager or consultant); this may include direct client interaction which should be well documented. * Develop and leverage knowledge of requirements and expectations for medical device submissions, understand the registration process, including whether tasks should be completed in parallel or sequentially and clearly delineate each process/phase to clients. * Assist with client documentation review, gap analysis, provide input regarding the acceptability of existing data, and explain how to satisfy the submission requirements. * Assist with or redirect internal or external inquiries related to quoting project hours and scope, including potential grouping or classification as applicable. * Escalate complex regulatory issues identified by team or clients to senior experts as appropriate and follow through to resolution. * Prepare regulatory reports. * Perform activities such as: - Research on regulatory issues, involving web searches, review of internal library and other means - Summarizing technical and regulatory information in a written form - Serve as Lead Consultant on multi-market research projects as needed - Handle client inquiries and provide consultation regarding medical device quality assurance and regulatory compliance issues, such as: - Drafting / reviewing mandatory or operating procedures needed for quality assurance or regulatory compliance - Reviewing product labeling - Responses to issues arising from registrar or regulatory inspections / audits. * Act as regulatory support on larger consulting project teams comprised of multiple stakeholders, including senior consultants, business development and project management. * Where appropriate, act as initial liaison with local regulatory authorities on behalf of clients. * Support Consulting team with RA and QA priorities as needed. Read and follow the Underwriters Laboratories Code of Conduct and follow all physical and digital security practices. A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers’ product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers’ products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage. When you combine the gravitas of a 130-year-old safety science leader with a culture of innovation that pushes the boundaries in new services and technology, you get UL Solutions. As a global team of business and engineering experts, we develop software for a huge range of industries, including medical, sustainability, renewable energy and healthy buildings. Together, we’re dedicated to making a real-world difference, to using our knowledge for good and to pioneering positive change. Join our team and use your expertise to transform global safety, security and sustainability.

Responsibilities

Assist clients with medical device registration, licensing applications, and regulatory compliance across various markets. Provide expert guidance on quality assurance, documentation review, and responses to regulatory audits.