Regulatory Affairs Specialist II - Fremont

ARK Diagnostics, Inc. is advancing the development of high-performance IVD assays that support precise clinical decision-making. We are looking for a Senior Clinical Affairs Specialist to lead the design and execution of clinical validation studies, ensuring that our products mee ...

Job Overview: · ARK Diagnostics, Inc. seeking a highly skilled and detail-oriented Regulatory Affairs Specialist II to join our team. In this role, you will be responsible responsible for supporting US/EU/UK/ROW device listing/registration, regulatory assessment of product or pro ...

ARK Diagnostics, Inc. is advancing the development of high-performance IVD assays that support precise clinical decision-making. We are looking for a · Senior Clinical Affairs Specialist · to lead the design and execution of clinical validation studies, ensuring that our products ...

Work Schedule · Standard (Mon-Fri) · Environmental Conditions · Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) · Job Description · As part of the Thermo Fi ...

Overview · ARK Diagnostics, Inc. is advancing the development of high-performance IVD assays that support precise clinical decision-making. We are looking for a Senior Clinical Affairs Specialist to lead the design and execution of clinical validation studies, ensuring that our p ...

Position Title: Sr. Staff Regulatory Affairs Specialist Job Location: 4245 Technology Drive, Fremont, CA Onsite) · Department: Regulatory Affairs Worker Category: Full-Time/Exempt · Job Industry: Neurovascular Devices Industry Function: Regulatory Affairs Specialist · Who We Want ...

We are looking for a Senior Staff Regulatory Affairs Specialist with Neurovascular / Neurointerventional Medical Devices Industry experience to join our team. · Prepare regulatory filing including 510(k), Q-submissions and 513(g). · Support labeling materials in all forms to foll ...

Q'Apel is looking for a Sr. Staff Regulatory Affairs Specialist with Neurovascular / Neurointerventional Medical Devices Industry experience. · Prepare regulatory filing including 510(k), Q-submissions and 513(g). · Support labeling materials in all forms to follow US and foreign ...

We are seeking a Regulatory Affairs Specialist for a 6-month temporary contract to support regulatory activities for medical devices. · Contribute to the preparation and support of regulatory submissions and filings for U.S. FDA and other global regulatory bodies. · Assess and do ...

· Who We Are · RefleXion is a privately held theranostic oncology company located in Hayward, CA, commercializing SCINTIX biology-guided radiotherapy, a novel therapy that uses a single radiotracer injection to turn cancer cells into real-time biological beacons to guide extern ...

The Regulatory Affairs Specialist supports and executes regulatory activities for medical devices across the product lifecycle, with increasing independence and responsibility. This role contributes to regulatory strategy, prepares and manages submissions and registrations, condu ...

The Regulatory Affairs Specialist supports global regulatory strategy and execution for medical device products ensuring compliance with FDA and international regulations throughout the product lifecycle. · ...

The Regulatory Affairs Specialist supports global regulatory strategy and execution for medical device products ensuring compliance with FDA and international regulations throughout the product lifecycle. · This role partners closely with R&D Quality Manufacturing and Clinical te ...

The Regulatory Affairs Specialist is a key partner to R&D, Quality, Manufacturing, and Marketing teams, responsible for driving regulatory strategy and ensuring compliance with global medical device regulations. · ...

+Job summary · The Regulatory Affairs Specialist supports global regulatory activities for a diagnostic product portfolio under the guidance of senior regulatory staff. · +Foundational understanding of regulatory requirements for medical devices or diagnostics. · Familiarity with ...

The Regulatory Affairs Specialist drives regulatory strategy and ensures compliance with global medical device regulations. · ...

We are hiring for a Regulatory Affairs Specialist to work on-site at our Santa Clara location.This new team member will combine knowledge of scientific regulatory business issues to enable products including combination products that are developed manufactured or distributed to m ...

We are presently hiring for a Regulatory Affairs Specialist to work on-site at our Santa Clara CA location. Prepares robust regulatory applications to achieve departmental and organizational objectives. ...

The Regulatory Affairs Specialist is a key partner to R&D, Quality, Manufacturing, and Marketing teams, · responsible for driving regulatory strategy and ensuring compliance with global medical device regulations. · Develop regulatory strategies for new product introductions and ...

Job Summary: · We are seeking a highly motivated Regulatory Affairs Specialist to support the Regulatory Affairs department in ensuring compliance with the Presidio Quality Management System (QMS) and applicable regulatory bodies. In this role, you will be responsible for the tac ...