Medical Device Product Reviewer
Thousands of us around the world wake up every day with a common purpose:
to make the world a safer, more secure and sustainable place. Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. We take delight in knowing that our work makes a meaningful contribution to society, and we are proud that our culture is centered on integrity, collaboration, inclusion and excellence. UL stands at the forefront of technological advancement, and we are continually challenged to find new ways to foster innovation and positive change. Satisfying? Yes. Exciting? Absolutely! As our global footprint continues to grow, we are seeking a MDR Product Reviewer/Auditor to join our team! The MDR Product Reviewer/Auditor is responsible for carrying out product-related reviews, such as technical documentation reviews or type examination, including aspects such as clinical evaluation, biological safety, sterilization and software validation. What you'll learn & achieve:
Determines project scope and specifications with substantial latitude for action or decision. Recommends changes in procedures, design or equipment where necessary. Initiates communication with clients to promote and explain the benefits of new and existing services. Communicates with clients to provide technical assistance in reference to complex product evaluation and/or inspection and follow-up services. Follows up on contacts from clients. Resolves technical issues and explains UL procedures and requirements. - Plans, conducts and supervises projects of major magnitude and scope. Determines areas in which the product is not in compliance with UL requirements or of any changes in project scope or specifications, and notifies client. Coordinates complex laboratory activities by developing data sheets. Coordinates administrative aspects of project management. May serve as Project Handler of record and may sign as Reviewer of record as assigned. Integrates continuous improvement concepts and techniques into all aspects of the job. Resolves complex engineering issues associated with Variation Notices by analyzing and reporting on the acceptability of the variations. Develops UL requirements for testing products beyond the scope of existing standards, or those involving unique features requiring frequent use of independent judgment. Develops special test methods and test equipment. Represents UL on technical committees of national and/or international organizations. Provides leadership and technical advice on special projects that involve complex, new or unusual issues. May provide direction as a Primary Designated Engineer or Designated Engineer for specific product categories. Performs special projects as directed. What makes you a great fit:
University degree or equivalent qualification in relevant studies, e.g. medicine, pharmacy, engineering or other relevant sciences; Four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed; Knowledge of device legislation, including the general safety and performance requirements set out in Annex I; Appropriate knowledge and experience of relevant harmonized standards, CS and guidance documents; Appropriate knowledge and experience of risk management and related device standards and guidance documents; Appropriate knowledge and experience of clinical evaluation; Appropriate knowledge of the devices which they are assessing; Appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those assessments. The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. UL has COVID-19 protocols and policies in place to ensure the safety of our employees, customers and clients. Effective November 1, 2021, the company mandates that employees are vaccinated against COVID-19 as a condition of employment (except where prohibited by law), subject to reasonable accommodation as required by law. What you'll experience working at UL:
Mission:
For UL, corporate and social responsibility isn't new. Making the world a safer, more secure and sustainable place has been our business model for the last 125 years and is deeply engrained in everything we do. People:
Ask any UL employee what they love most about working here, and you'll almost always hear, the people. Going beyond what is possible is the standard at UL. We're able to deliver the best because we employ the best. Interesting work:
Every day is different for us here as we eagerly anticipate the next innovation that our customers' create. We're inspired to take on the challenge that will transform how people live, work and play. And as a global company, in many roles, you will get international experience working with colleagues around the world. Grow & achieve:
We learn, work and grow together with targeted development, reward and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles. Total Rewards:
In the US, we provide lots of great benefits for our employees are their families. From Volunteer Days off to 401k match and retirement contribution benefits to flexible work location & schedule options we look to support our employees no matter what stage in life they are experiencing.
Salary Range:
$80K -- $100K
Minimum Qualification
Healthcare ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
to make the world a safer, more secure and sustainable place. Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. We take delight in knowing that our work makes a meaningful contribution to society, and we are proud that our culture is centered on integrity, collaboration, inclusion and excellence. UL stands at the forefront of technological advancement, and we are continually challenged to find new ways to foster innovation and positive change. Satisfying? Yes. Exciting? Absolutely! As our global footprint continues to grow, we are seeking a MDR Product Reviewer/Auditor to join our team! The MDR Product Reviewer/Auditor is responsible for carrying out product-related reviews, such as technical documentation reviews or type examination, including aspects such as clinical evaluation, biological safety, sterilization and software validation. What you'll learn & achieve:
Determines project scope and specifications with substantial latitude for action or decision. Recommends changes in procedures, design or equipment where necessary. Initiates communication with clients to promote and explain the benefits of new and existing services. Communicates with clients to provide technical assistance in reference to complex product evaluation and/or inspection and follow-up services. Follows up on contacts from clients. Resolves technical issues and explains UL procedures and requirements. - Plans, conducts and supervises projects of major magnitude and scope. Determines areas in which the product is not in compliance with UL requirements or of any changes in project scope or specifications, and notifies client. Coordinates complex laboratory activities by developing data sheets. Coordinates administrative aspects of project management. May serve as Project Handler of record and may sign as Reviewer of record as assigned. Integrates continuous improvement concepts and techniques into all aspects of the job. Resolves complex engineering issues associated with Variation Notices by analyzing and reporting on the acceptability of the variations. Develops UL requirements for testing products beyond the scope of existing standards, or those involving unique features requiring frequent use of independent judgment. Develops special test methods and test equipment. Represents UL on technical committees of national and/or international organizations. Provides leadership and technical advice on special projects that involve complex, new or unusual issues. May provide direction as a Primary Designated Engineer or Designated Engineer for specific product categories. Performs special projects as directed. What makes you a great fit:
University degree or equivalent qualification in relevant studies, e.g. medicine, pharmacy, engineering or other relevant sciences; Four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed; Knowledge of device legislation, including the general safety and performance requirements set out in Annex I; Appropriate knowledge and experience of relevant harmonized standards, CS and guidance documents; Appropriate knowledge and experience of risk management and related device standards and guidance documents; Appropriate knowledge and experience of clinical evaluation; Appropriate knowledge of the devices which they are assessing; Appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those assessments. The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. UL has COVID-19 protocols and policies in place to ensure the safety of our employees, customers and clients. Effective November 1, 2021, the company mandates that employees are vaccinated against COVID-19 as a condition of employment (except where prohibited by law), subject to reasonable accommodation as required by law. What you'll experience working at UL:
Mission:
For UL, corporate and social responsibility isn't new. Making the world a safer, more secure and sustainable place has been our business model for the last 125 years and is deeply engrained in everything we do. People:
Ask any UL employee what they love most about working here, and you'll almost always hear, the people. Going beyond what is possible is the standard at UL. We're able to deliver the best because we employ the best. Interesting work:
Every day is different for us here as we eagerly anticipate the next innovation that our customers' create. We're inspired to take on the challenge that will transform how people live, work and play. And as a global company, in many roles, you will get international experience working with colleagues around the world. Grow & achieve:
We learn, work and grow together with targeted development, reward and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles. Total Rewards:
In the US, we provide lots of great benefits for our employees are their families. From Volunteer Days off to 401k match and retirement contribution benefits to flexible work location & schedule options we look to support our employees no matter what stage in life they are experiencing.
Salary Range:
$80K -- $100K
Minimum Qualification
Healthcare ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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