Plymouth, MN, 55446, USA
6 days ago
Medical Device Regulatory Technician
Description: The product surveillance analyst or postmarket surveillance lab analyst in this role performs evaluations on various types of returned devices associated with reported complaints. Analysis involves using procedures, judgment and experience to determine appropriate testing of returned products; determining a well-documented and accurate root cause evaluation; reviewing of Device History Records; coordinating product testing/analysis with other internal departments and external consultants; and preparing technical reports of evaluations. During the file management portion of this role, one is responsible for receiving the complaints from the customer/field, asking questions, and submitting evaluations on findings. This position will analyze and submit complaints and/or investigate returned products from the field (some biohazard as they are used in surgery). Additional Skills & Qualifications: Bachelors Degree in a science related field (biology, biochemistry, neuroscience, etc) 0-2 years of experience within a lab or medical space Technical writing experience Research skills Proven ability to communicate effectively and efficiently (verified by references) Proven strong communication skills (verified by references) Strong customer service skills Preferred Qualification: 1+ years of working experience post-college (can be in any field but technical is preferred) Experience with root cause analysis/failure analysis 3+ months lab experience and/or anatomy/physiology experience but is not premed They like to see someone with lab experience, TA experience or research experience (can be from college) The Product Surveillance Analyst must be able to: Collaborate independently with other team members and departments needing product complaint information. Use procedures, judgment and experience to determine appropriate testing of returned products with minimal guidance. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Ability to leverage and/or engage others to accomplish projects. Ascertain when additional support may be needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues). Poses and apply strong analytical and problem solving skills. Experience Level: Entry Level About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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