REMOTE Medical Affairs IVDR Specialist
Company: GForce Life Sciences
Posted on: January 16, 2022
GForce Life Sciences' mission is to make an impact one person at a
time. We do this by assisting our clients, consultants, colleagues,
charities, and the clinical space. As one of America's Fastest
Growing Private Companies (#8 in 2018 and #90 in 2019; identified
by the Inc. 5000 rankings) as well as a repeat Best Company to Work
For (Staffing Industry Analysts), our primary focus is matching
highly targeted consultants to executives' needs in the medical
device, pharmaceutical and biotech industries. Headquartered in
Chicago with a presence in Boston, San Francisco, Florida and
twenty other states, GForce has successfully been engaged in
hundreds of engagements in many countries for clients ranging from
Fortune 500 to startups.
We consider our consultant employees to be the most important piece
of the puzzle in this extremely competitive environment. Combine
that with our deep client relationships, and attention to detail,
and we feel strongly that this provides us with a strong advantage
in the life sciences consulting industry.
Duties / Expectations of Role
Responsible for contributing to the implementation and execution of
post-market In Vitro Diagnostic Regulations activities through
medical assessments of LD products.
Serve as medical consultant to project teams for preparation of
IVDR performance evaluation reports.
Advise on medical risks and benefits to evaluate product safety and
effectiveness in laboratory medicine in support of functional group
activities for commercialized products and new product
Work independently or as part of a larger team in the execution of
Perform literature-based searches to identify potential product
risks across all LD product lines, including hardware, software and
Actively collaborate with cross-functional key stakeholders
(Commercial Product Quality, Risk Management, Clinical Affairs,
etc.) in support of post market surveillance plan and report
creation to assess the safety, effectiveness and performance of our
Maintain accurate documentation and files related to risk-benefit
analyses and/or post-market surveillance activities.
Interacts directly with regulatory, clinical, marketing,
manufacturing, and R&D as needed during the course of
risk-benefit analyses and/or post-market surveillance activities
and builds productive cross-functional working relationships.
Critically reviews analytical and clinical performance data and
reports and provides assessments of overall scientific and
Perform special assignments and provide technical and clinical
advice in area of expertise.
Preempts potential problems via post-market surveillance and
provides effective input to potential safety impact of identified
M.D., Ph.D. or M.D./PhD. In related areas with practical experience
in clinical pathology preferred.
Equivalent combination of relevant education and experience, such
as Masters in medical technology, laboratory science, chemical,
physical, or biological science AND a minimum of 3 years of medical
laboratory experience in clinical consultancy and technical and
regulatory oversight, as outlined above, may be substituted as
Board certification and ongoing accreditation by nationally and
internationally known professional clinical and academic bodies
such as ABCC, NRCC, CACB, RCP, ABP preferred.
Typically 3 to 5 years of successful experience in related
laboratory medicine or medical device field.
Experience in post-market surveillance.
Nice to Have Requirements
Experience with ISO13485/2016 and/or IVDR EU 2017/746 is highly
Term & Start
12+ month contract
Remote - EST
Employer contributed competitive health benefits (medical, dental,
Philanthropy driven culture
Consultant engagement social activities
Keywords: GForce Life Sciences, Columbus , REMOTE Medical Affairs IVDR Specialist, Healthcare , Columbus, Ohio
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