Provides consulting services to medical device clients on quality assurance and regulatory compliance. Responsibilities include preparing FDA 510(k) and international submissions, compiling technical documentation, implementing and auditing QMS against ISO 13485, QSR, MDSAP, EU MDR and IVDR requirements, performing regulatory research, preparing clinical evaluation reports, managing risk documentation, addressing regulatory deficiencies, and advising on testing, labeling, and marketing materials.
JOB DESCRIPTION
The Senior Quality & Regulatory Affairs Consultant will work within Emergo's consulting team, providing assistance with regulatory and quality compliance issues to clients in accordance with written Work Instructions and the signed proposal / SOW.
RESPONSIBILITIES
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:
QUALIFICATIONS
OTHER DESIRED COMPETENCY AND QUALIFICATIONS:
ABOUT US
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.
The Senior Quality & Regulatory Affairs Consultant will work within Emergo's consulting team, providing assistance with regulatory and quality compliance issues to clients in accordance with written Work Instructions and the signed proposal / SOW.
RESPONSIBILITIES
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., 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.
QUALIFICATIONS
- Bachelors' degree in a science discipline such as biomedical engineering, Quality engineering, microbiology or chemistry
- 5 years of Quality Assurance and Regulatory Affairs industry experience, ideally at a team lead / supervisory level.
- A demonstrated knowledge and understanding of global medical device regulations, especially MDSAP countries and the EU / UK. / LatAm
- Experience with writing and compiling technical documentation.
- Experience with risk management files (ISO 14971).
- Client-facing experience and strong interpersonal skills.
- Fluency in English.
OTHER DESIRED COMPETENCY AND QUALIFICATIONS:
- Post-graduate degree.
- Lead auditing experience (QSR, ISO 13485, MDSAP).
- Clinical Evaluation report preparation.
- Experience with IVDs and/or device software / SaMD.
- Experience with presenting training to groups.
- Fluency in additional languages.
ABOUT US
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.
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