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Regulatory Affairs Specialist-4694
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Infosoft Palo Alto, United StatesOne of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position. · Here are the job position details for ...
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Regulatory Affairs Specialist(W2 Only)
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Regulatory Affairs Specialist
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Clinical Affairs Specialist 3
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Sr. Regulatory Affairs Specialist
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GForce Life Sciences Santa Clara, United StatesRegulatory Affairs Specialist– Santa Clara, CA · Must be able to work on a W2 · Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and comme ...
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Regulatory Affairs Specialist
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GForce Life Sciences Santa Clara, United StatesRegulatory Affairs Specialist Santa Clara, CA · Must be able to work on a W2 · Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and comm ...
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Recor Medical Palo Alto, CA, United StatesAt Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. The Principal Regulatory Affairs Specialist will be an individual contributor that will bring exceptional technical regulato ...
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Principal Regulatory Affairs Specialist
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Recor Medical Palo Alto, CA, United StatesAt Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non- ...
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Regulatory Affairs Specialist
2 days ago
INTELLECTT INC Santa Clara, United StatesHello, · Hope you are doing well. · This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to or call me at · Role: · Regulatory Specialist II · Location: · Santa Clara ...
Principal Regulatory Affairs Specialist - Mountain View, United States - BioLink 360
Description
Reports to:
Senior Director of Regulatory and Quality
Salary Range:
K
Location:
San Jose, CA (hybrid position)
This is an established privately held medical device company with a focus in delivering innovative navigation diagnostic and therapeutic technologies.
Their reach is global and they are the industry leader in their specialty, with a second location in Asia.The investment into R&D is significant with several products in the pipeline at various stages and their financial standings are strong.
The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed.
ResponsibilitiesSupport and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction.
Provide guidance and approval regarding regulatory strategies and approaches.Develop, Maintain and update regulatory documents such as technical files for CE marking, device master records, GSPR checklist, risk analysis, and design history files.
Participate and Support new product development teams to provide regulatory support to the project.Assess regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging and notifying regulatory agencies and NB of substantial changes.
Support post market activities and reportability to regulatory agencies.Required to support communication with FDA and the Notified Body, preparing responses to questions or deficiency letters from regulatory agencies, and serve as the RA Representative during FDA and NB site audits.
Qualifications5-10 years experience in regulatory affairs within the medical device industry
Strong experience in EUMDR Regulations (Medical Device directives (93/42/EC)
Authoring experience in FDA product submissions (IDE, PMA, 510k)
Experience in writing/maintaining CE Technical Files preferred
Experience with ISO 13485:2016 and ISO 14971
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