Senior Quality & Regulatory Affairs Consultant at UL Solutions External Career Site

, , North Korea -

Full Time

Start Date

Immediate

Expiry Date

30 Aug, 26

Salary

0.0

Posted On

01 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Affairs, Medical Device Regulations, QMS Implementation, Internal Auditing, Technical Documentation, Risk Management, Clinical Evaluation Reports, Regulatory Submissions, ISO 13485, FDA 510(k), MDSAP, EU MDR/IVDR, MFDS Compliance, Client Relationship Management, Interpersonal Skills

Industry

Professional Services

Description

* Provide Quality and/or Regulatory consulting services, independently or with oversight by a Lead QA/RA Consultant or Consultant Manager, which may include but are not limited to: Leverage regulatory affairs experience gained in the medical device industry/medical device consulting to provide client support with Quality Assurance and Regulatory compliance requests, help resolve client issues, and respond to market-specific inquiries. * Prepare/review local or international regulatory submissions e.g., MFDS, FDA 510(k) for or on behalf of manufacturers, demonstrate and share knowledge of requirements by market and compile/review technical documentation files for compliance to applicable regulations; raise concerns where any are identified, provide guidance for resolution. * Perform research on regulatory affairs requested for standard or nuanced market environments and generate peer reviewed reports. * Provide Quality Assurance consulting services, such as: - Implementation of new Quality Management System (QMS) to ISO 13485, QSR, MDSAP, EU regulations, etc. * Draw from medical device industry experience for analysis of existing client QMS against requirements and gap closure and remediation as needed - Conduct Internal audits / Supplier audits for manufacturers, distributors and vendors - Maintenance and/or updating of QMS with additional requirements (e.g., MDSAP, EU MDR/IVDR)Provide Regulatory consulting services, such as: - Research and prepare regulatory classification and strategy / pathway reports * Review and identify gaps in technical / regulatory documentation- Prepare premarket submissions to regulatory authorities - Perform literature searches and prepare Clinical Evaluation Reports- Assist in addressing and responding to deficiencies of product submissions identified by regulatory authorities - Guidance on testing requirements to support marketing submissions. * Review and advise on labeling and marketing materials, including written documents and website. * 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. We solve our customers’ problems. Within Software & Advisory (S&A) services, UL Solutions’ Product Lifecycle business helps our customers accelerate initial global market access and enhanced post-market longevity, and help achieve full lifecycle commercial compliance.

Responsibilities

Provide Quality Assurance and Regulatory Affairs consulting services to medical device clients, including the preparation of regulatory submissions and QMS implementation. Conduct internal and supplier audits while ensuring compliance with global standards such as ISO 13485 and EU MDR.