Remote: Regulatory / Clinical Consultant (221953)

Clinical Research & Clinical Affairs | Life Sciences & Technology
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Job Description:

The client needs a senior level regulatory / clinical consultant that can help to revise the client’s regulatory plan and 510(k) strategy for a device that is getting ready for electrical safety testing and may be about 6 plus months away from being ready for submission. The consultant will need to be able to evaluate the product, strategy and plan and develop plans for clinical studies (high-level overview) which may involve clinical studies and/or hospital exemptions. They will need to detail the risks, action items and detail the clinical study strategy. The device is not a new device, but rather adds a cooling element to help reduce neurological damage and reduce risk of infection during surgeries. Additionally, they would like the consultant to also have experience with setting up/conducting meetings with the regulatory authorities (FDA and Health Canada) to review regulatory and clinical strategy/planning. The client envisions using the consultant a few times over the next 6 months for about 1-2 weeks (about 30 hours) at a time.

 

Remote: Regulatory / Clinical Consultant (221953)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
US Remote

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