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Company Name:
Approximate Salary:
Per Year
Location:
Northbrook, Illinois
Country:
United States
Industry:
Other
Position type:
Full Time
Experience level:
Not Specified
Education level:
Bachelor's Degree

IVD Product Specialist/Auditor

Overview:

UL
UL is a global independent safety science company with more than a century of expertise innovating safety solutions from the public adoption of electricity to new breakthroughs in areas such as sustainability, renewable energy, mobile payment security and nanotechnology. Dedicated to promoting safe living and working environments, UL helps safeguard people, products and places in important ways, facilitates trade and provides peace of mind. Our 1,000+ Standards of Safety serve as the bedrock of compliance for nearly 200 different industries. The UL mark is accepted worldwide and our reputation for public safety and helping manufacturers around the globe build safer products is unmatched. More than 11,000 employees together with representatives and business partners serve customers locally in over 100 different countries. To build up our Regulatory Medical business in Europe we are looking for:

Certification decision maker (assessor and auditor)
In Vitro Diagnostic Technologies
Location: USA
*This position is remote and can be located anywhere in the United States
Certification Certification

Responsibilities:

In Vitro Diagnostics Medical Devices are some of the most regulated products in the world. In this role, you will be a part of the UL Medical Regulatory Team. Working with limited supervision, you will independently assist and support processing of manufacturer submissions to the IVD Directive 98/79/EC and, where applicable, ISO13485. Within the framework of our highly regulated Notified Body you will:

  • Perform contract review / project planning for technical file/design dossier evaluations and quality management system audits.
  • Assess technical file/design dossier and quality management systems against European Directives, essential requirements and latest common technical specifications.
  • Support regular quality system and technical audits, including unannounced audits.
  • Subject to training and qualification milestones, perform key CE certification decision making responsibilities to support safe products to market.
  • Perform key development and support of UL's IVD processes for future CE IVD Regulations;
  • Participate in development and delivery of training materials to UL assessors.
  • Support Competent Authority (MHRA) activities on as needed basis e.g. MHRA audits of UL.
  • Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.
  • Provide guidance and support to customers as required. Participate in client training and customer forums.
  • Overseas travel is required.


Qualifications:

Required:
  • At least a Degree or equivalent in Life Science discipline e.g. Biochemistry, Applied Biology. PhD would be an advantage.
  • At least 4 years hands-on experience within In Vitro Diagnostics Industry in one or more of the following roles - R&D, Manufacturing or Quality Assurance/Regulatory Affairs.
  • Working knowledge and thorough understanding of the principles of following areas: Immunoassay (all currently available variants), NAT, Rapid Assay Formats, Self-test device technologies and general serology devices. UL is particularly interested in candidates with Molecular Biology expertise.
  • Hands-on knowledge of design, evaluation and manufacture of assays mentioned in In Vitro Diagnostics Directive: List A (ABO, rhesus, anti-Kell blood grouping, HIV, HTLV Hepatitis B, C, D), List B (Anti-Duffy, anti-Kidd blood grouping, Irregular anti-erythrocyte blood grouping, Rubella, Toxoplasma, PKU, Cytomegalovirus, Chlamydia, HLA (DR, A, B) Tissue typing, PSA, Trisomy 21, Blood sugar self-test, Self Test Devices (Allergy, Cholesterol, Pregnancy, Ovulation, Osteoporosis etc).
Desired:
  • Auditing experience, ideally with another registration body. IRCA member.
  • Experience with ISO 13485/9001.
  • Fluent English language skills essential and other language skills desirable.
  • Able to demonstrate UL's Critical Behaviors for Success to Level C to include: -
  • Process orientated to deliver business success;
  • Excellent verbal and written communication skills;
  • Confident, calm and decisive personality;
  • Strong innovative and analytical skills;
  • Ability to deal professionally with confrontation.


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