Regulatory Affairs Lead - Medical Devices & IVD (Remote)
QuidelOrtho
- Remote job
QuidelOrtho seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for new in‑vitro diagnostics and medical devices in worldwide markets. You will manage U.S. submissions, interact with FDA and global agencies, and ensure compliance with QSR, ISO, CMDR, IVDR, and CFR requirements. This role is remote eligible. The position requires leadership, cross‑functional collaboration, and the ability to work independently on high visibility projects across regulatory disciplines. #J-18808-Ljbffr QuidelOrtho
$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...Remote workMedical device- ...their merit.Job Function: Regulatory Affairs GroupJob Sub Function:... ...States of America, Remote (US), Santa Clara,... ...Regulatory Affairs Program Lead to support our... ...feedback for specifications, device testing, risk... ...Affairs experience within Medical Device is required (4+...Remote workMedical deviceFull timeLocal areaImmediate start
$160k - $180k
...Compliance Lead Columbus, Ohio; Irvine, California; or Remote within the U.S. About Aegis Ventures... ...previously impossible medical challenges, bringing... ...biopharma research, medical device innovation, AI model... ...program turning our regulatory obligations into a scalable...Remote workMedical device- ...Reference26-00910Remote50% Remote Job Description Key Responsibilities · Lead FDA audit and... ...interface for FDA inspections, regulatory meetings, and... ...with Quality, Regulatory Affairs, Manufacturing, Engineering... ...industries such as Pharma, Medical Devices, Biotechnology, or...Remote workMedical device
$250k - $275k
...academic institutions and leading players in biopharma... ...of FDA-regulated medical device products, including in... ..., Quality, Clinical, Regulatory Affairs, Manufacturing, and... ...position will be fully US remote . In this... ...market interactions, IVD and RUO marketing...Remote workMedical deviceWork from homeWorldwideFlexible hours$110k - $135k
...everything possible. The Principal Regulatory Affairs Specialist is responsible... ...of new and modified IVD medical devices and software while acting as... ...Boulder, COand will be fully remote. In this role, you will... ...opportunity to: Author and lead the creation of regulatory...Remote workMedical deviceFull timeLocal areaWork from homeFlexible hours$55.03 per hour
...Inc. Job Title: Senior Regulatory Affairs Specialist Pay Rate: $50... ...months Location: Irvine, CA/Remote (9 am to 6 pm PST time zone... ...) Our Client is a Global medical device Manufacturer. We are... ...Regulatory Affairs Specialist, IVD California, United States...Remote workMedical deviceFull timeWork at office- Siemens Healthineers AG is looking for a Regulatory Affairs Professional to join their team in Walpole, MA. This hybrid position entails... ...discipline and at least 2 years of experience in IVDs or medical devices. Strong knowledge of US/EU regulations and good attention...Medical device
- ...high-performing teams drive groundbreaking medical discoveries and invite all applicants to... ...and replacement of malfunctioning devices from service.Uses data indicators to schedule... ...Constantly (67-100%)Hearing Constantly (67-100%)Remote TypeHybridWork Location100 Blossom...Remote workMedical device
- The Regulatory Affairs Manager will create, evaluate and... ...matters.This is a Remote opportunity Pay... ...offered may include:· Medical/Prescription Drugs... ...vitro diagnostic (IVD) regulatory... ...IVD and/or medical device regulations outside... ...requirements.Skills:Able to lead and drive...Remote workMedical deviceFull timeTemporary workPart timeWork experience placementWorldwideFlexible hours
$190k - $284k
...work. We are looking for a Global Industry Lead, Healthcare to help define and scale our... ...healthcare technology, digital health, medical devices, enterprise software, or adjacent... ...such as clinician workflow efficiency, remote expertise, training and simulation, patient...Remote workMedical deviceFull timeLive inWork at officeLocal area$136.86k - $195.51k
...diseases with high unmet medical need. Learn more... ...& Scope The Lead, Upstream Marketing... ...with Sales, Medical Affairs, Market... ...Market Access, Legal, Regulatory, and Compliance to... ...biotechnology, medical device, or healthcare industries... ..., Illinois. Remote work from anywhere...Remote workMedical deviceWork at officeWork from homeWorldwide$29.8 - $47.7 per hour
...Manufacturing Team Lead BD is one of the largest global medical technology companies in the world. Advancing the... ...and leadership skills. Medical device manufacturing experience preferred... ...flexibility and work-life balance. Remote or field-based positions will have...Remote workMedical deviceHourly payWork at officeShift workDay shiftAfternoon shift$156.6k - $234.9k
...product design? Want to help lead a once in a lifetime career program... ...meet FDA guidelines for a medical device experience but hold a high... ...partners such as Human Factors, Regulatory, Compliance as well as Legal.... ...Excellence Award for remote work; recognized as a Great Place...Remote workMedical deviceFull timeWork at office- ...Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-... .../ Procurement Management experience in medical device and/or a regulated manufacturing environment... ...office workspace or remote/home (hybrid). Flexibility to manage suppliers...Remote workMedical deviceFull timeContract workSummer workWork at officeShift work
- ...Shipping Lead - Monday-Friday, 7:30am-4:00pm The Shipping Lead is responsible for... ...for customers who are getting life-saving medical devices to the frontlines of healthcare,... ...for roles based in Washington state or remote roles that would be worked from Washington...Remote workMedical deviceTemporary workLocal areaMonday to FridayFlexible hoursShift work
$170k - $185k
...Diagnostics, creating a world-leading in vitro diagnostics... ...as our next Senior Regulatory Affairs Manager. This role... ...diagnostics and medical devices into the worldwide market... .... This position is remote eligible for candidates... ...devices and/or IVD products. Works as primary...Remote workMedical deviceWork experience placementWork at officeLocal areaWorldwideHome officeNight shift$117.77k - $161.93k
...their career. This is a remote role. As a Senior Regulatory Affairs Specialist, you will be... ...Independently or collaboratively lead and contribute to... ...standards applicable to medical device market clearance Knowledge of point-of-care IVD products and applicable...Remote workMedical deviceTemporary workWork at officeLocal area$35 - $40 per hour
Regulatory Affairs SpecialistRemote - Memphis preferred, open to remote candidates so please specify location/time zone on resume2... ...modified devicesWork as the RA lead on project teams... ...country-specific requirements, medical devices and medical terminologyPlan,...Remote workMedical deviceContract work$175k - $225k
...growing, Boston-based medical technology company... ...care - leading to better patient outcomes... ...patient care, and regulatory strategy is how it... ...years of Regulatory Affairs experience in the medical device industry, with a track... ...to apply as fully-remote employees.Salary Range...Remote workMedical deviceWork at officeLocal area- ...Medical Device QA Auditor Join the GMED team today and work on the... ...Location(s): Rockville, MD or Remote (Home office) Job Description... ...with all GMED, scheme and regulatory requirements to assure... ...the US subsidiary of GMED, a leading Certification Organization,...Remote workMedical deviceFull timeContract workTemporary workWork experience placementWork from homeWorldwideHome officeFlexible hours
- BioRobotics is looking for a Principal Regulatory Affairs Specialist to provide regulatory leadership from product development through marketing... .... The role requires a minimum of 12 years in the medical device industry, with strong knowledge of regulatory standards and...Medical device
- ...Lead Software Architect United States... ...expertise across medical imaging workflows,... ...screening medical devices. Promotes and leads... ...service, quality, regulatory and SQA in defining... ...Assurance, Clinical Affairs and other... ...disability and veterans. #LI-AH1 #remote...Remote workMedical deviceLocal area
- ...Regulatory Affairs Specialist 12-month contract Remote CST hours (Local to Cary, IL is preferred) Must be able to work on a W2 Job Responsibilities... ...of experience in regulatory affairs within the medical device industry. ~ Strong knowledge of U.S. FDA 510(k...Remote workMedical deviceContract workLocal area
$86.7k - $173.3k
...technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our... ...large data setsAbility to work seamlessly with remote sites & business partners including building relationship...Remote workMedical deviceContract workWork at officeShift work- LHH is seeking a Senior Regulatory Affairs Specialist in Dublin, California to support global regulatory strategies for medical devices. The role involves preparing submissions, leading communications with regulatory agencies, and ensuring compliance with evolving regulations...Medical device
- AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device to develop and execute regulatory strategies for on-market and development products in the US and Canada. You will coordinate lifecycle activities, interface with Health...Medical device
$220k - $290k
...difference in people's lives. Our medical devices, software and related... ...Director, Chief Privacy Lead (CPL) serves as the enterprise... ...stakeholders across Legal, Regulatory Affairs, IT, Cybersecurity, R&D,... ...position is filled. For fully remote positions, compensation...Remote workMedical deviceMinimum wageOngoing contractFull timePrivate practiceLocal areaWorldwide$135k - $159k
...Lead Clinical Research Associate We opened our doors with a clear and simple vision... ...the pharmaceutical, biotechnology, and medical device industries. What fuels our focus? Most... ...Willingness to travel and perform remote and on-site monitoring, if needed Proficiency...Remote workMedical deviceContract workInterim roleWorldwide$75k - $90k
A leading healthcare consultancy is seeking a Regulatory Affairs Project Lead in Buffalo Grove, IL. The role involves managing regulatory submissions and collaborating with various teams to ensure compliance, particularly in the Canadian market. Candidates should have...Medical deviceMonday to Friday
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