Regulatory Affairs Lead - Medical Devices & Software
Pascall Systems, Inc.
PASCALL Systems is seeking a Regulatory Affairs professional in Cambridge, MA to drive regulatory strategy and coordinate FDA/CE submissions for our EEG-based medical device platform. You will work closely with product, clinical, and quality teams to ensure design controls, risk management, and labeling align with FDA expectations. Ideal candidates bring 4–6 years in regulated medical devices, strong writing skills, and the ability to balance risk with business needs in a small company #J-18808-Ljbffr Pascall Systems, Inc.
- ...Computer System Validation (CSV) Lead to oversee validation... ...management, FDA and global regulatory compliance, validation documentation... ...periodic reviews. Support software implementation, upgrades,... ...pharmaceutical, biotechnology, medical device, or life sciences industry....SoftwareMedical 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... ...when required including those requiring software revision.Acts as first line resource for...SoftwareMedical deviceRemote work
- ...experienced and highly motivated Regulatory Manager to join our Regulatory Affairs team. In this role, you... ...agencies, and lead cross-functional teams... ...pharmaceutical, biotech, or medical device industries. ~ In-... ...with regulatory software or databases is preferred...SoftwareMedical deviceContract workWork at office
- ...We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this role, you will... ...the pharmaceutical, biotech, or medical device industries. ~ Familiarity with... ...and familiarity with regulatory software or databases is a plus. Locations...SoftwareMedical deviceContract workWork at office
$132k - $165k
...Function: Clinical & Medical AffairsPay Type: Salary... ...the medical device industry? AngioDynamics... ...Auryon System, a market-leading technolog y that interventionalists... ...with Clinical Affairs, Regulatory Affairs, Health care... ...following computer software applications: MS...SoftwareMedical deviceContract workRemote work- ...team This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated)... ...products globally Leads and manages regulatory... ...less senior Regulatory Affairs professionals, including... ...) Required Computer / Software Skills: Proficiency with...SoftwareMedical deviceWork at office
$163k - $173k
...are seeking an AppSec and DevSecOps Lead to join our team. This is a hybrid opportunity... ...will embed security throughout the software and infrastructure lifecycle—from... ...across cloud services, endpoints, medical and shared-use devices, APIs, virtual environments, legacy systems...SoftwareMedical deviceWork at officeLocal areaRemote work$225k - $260k
...Advanced Staining Reagents leads scientific aspects of global... ...Pathology, R&D, Clinical, Regulatory, Commercial, Sales and Marketing... ..., digital pathology, software as a medical device and oncology or cancer diagnostics... ...management, medical affairs, clinical development or commercial...SoftwareMedical deviceFull timeRemote workWork from homeFlexible hours$221.9k - $390.3k
...to level-up your career at the company leading workforce transformation in the agentic... ...enterprise pharmaceutical, biotech, and medical device accounts — guiding customers through... ...enterprise product company delivering software-based solutions7+ years of dedicated Customer...SoftwareMedical deviceFull time$227k - $362k
...Marketing Leader to build and lead the Claims, Value & Pricing... ...or related work in a global medical device or healthcare technology... ...experience working with clinical, regulatory, legal, quality and... ...that bring together devices, software, services or data-enabled solutions...SoftwareMedical devicePrice workFull timeWork experience placementWork at officeImmediate start3 days per week$120k - $202.5k
...Intelligence Compliance & Automation Lead who will play a critical role... ..., workflow efficiency, and regulatory alignment across the... ...combination of technical expertise, software development experience,... ...coverage including basic life, medical, dental, vision, long-term disability...SoftwareFull timeTemporary workFlexible hours- ...patient lives by 2030 by helping regulated software teams move faster without sacrificing... ...front lines of our mission to make the medical device industry safer by helping these... ...booking meetings; it's about shaping how leading and emerging life sciences companies build...SoftwareMedical deviceH1bWork at officeWorldwideWork visa
$150k - $180k
...options About Ketryx Ketryx is an AI software platform that enables healthcare and... ...life-saving products A strong inbound lead flow and massive, untapped TAM A collaborative... ...ability to connect with leaders in the medical device industry. ~ Currently in the Greater...SoftwareMedical deviceFull timeWork at officeImmediate startRelocationMonday to FridayShift work$147.4k
...optics, computing, artificial intelligence, hardware, communications, software, transportation, and/or energy technologies, therapeutic, diagnostic, drug delivery, genetic engineering, medical device, biomanufacturing, biomaterials and/or drug discovery technologiesPlease...SoftwareMedical deviceFull timeWork at officeVisa sponsorship$280k - $350k
...transparency across connected devices and software supply chains. Our platform... ...software supply chain, and regulatory compliance challenges. Priority... ...include automotive, medical devices, industrial and operational... ...complex sales cycles. Lead opportunities from discovery...SoftwareMedical deviceContract workRemote work$133.26k - $168.79k
...retired in accordance with global regulatory requirements, industry... ...Annex 11, and FDA's Computer Software Assurance (CSA) guidance.... ...issue resolution, etcAbility to lead and coordinate cross-... ...pharmaceutical, biotechnology, medical device, or similar).EyePoint is committed...SoftwareMedical device$78k - $113k
...liabilities within Boston Medical Center (BMC) and... ...Case Management Leads investigations (interviews... ...committee review 4. Regulatory & Compliance Reporting... ...with Safe Medical Devices Act (recalls) Keeps... ...adverse event reporting software (RL Solutions). Occasionally...SoftwareMedical deviceFixed term contractWork at officeFlexible hours3 days per week$175k - $250k
...from cutting-edge products to life-saving medical devices. Our 3D printing technology powers... ...engage in financial planning activities that lead decisions and operations.Take lead in... ...Adaptive Planning & NetSuite.Experience in Software/Tech/Hardware industries.MBA, CPA or CMA...SoftwareMedical deviceFull timeWork experience placementWork at officeWorldwideFlexible hours$94k - $148k
Snyk is the leader in secure AI software development, helping millions of developers develop fast and stay secure as AI transforms how software... ...ahead as AI reshapes our world.Job SummarySnyk is looking for a Lead Procurement Business Partner to serve as the strategic...SoftwareFull timeContract workWork at officeWork from homeFlexible hoursShift work3 days per week$134.5k - $265.1k
...deploy, and operate integrated/verticalized sector solutions in software, data, AI, network, and hybrid cloud infrastructure. These solutions... ...seeking a visionary and results-oriented professional to help lead our Life Sciences Commercial Operations practice, specializing...SoftwareLocal areaVisa sponsorship- ...as a variable cost.Job Description• The Regulatory Affairs Operations (RA Ops) submission group is... ...in coordination with Global Regulatory Leads. The role works to tight, business-... ...Professional, Adobe Add-ins, Publishing Software (sCubed and/or eCTD Manager), Validation...SoftwareImmediate start
$117k - $175k
...working at least three days a week in the office. As a Senior Lead Health Actuarial Consultant , you will manage client projects... ...analyses and cost projections using tools like Excel, SAS, and other software, with potential specialization in healthcare-related insurance...SoftwareMinimum wageWork at officeLocal areaRemote workFlexible hours3 days per week1 day per week$158k - $214k
...solutions to meet themExpertise with some or all of the following software: Tableau, SQL, Python, MS Office, Google Suite, Akur8Note on... ...to our benefits package, consisting of our partially subsidized medical plan, fully subsidized vision/dental options, life insurance,...SoftwareFull timeLocal areaFlexible hours- ...on PLC and HMI programmingProcess Engineering with a focus on process developmentMold design - low cavitation and high cavitation Molding process engineeringSummaryType: ContractFunction: Information TechnologyExperience level: Not ApplicableIndustry: Computer SoftwareSoftwareMedical deviceWork at office
- ...area are to be on the leading edge of improving health... ...staff and reviewing medical records for evaluation... ...of improvement, and/or regulatory liability reporting.... ...requirements of the Safe Medical Devices Act. Submits related... ...event reporting software (RL6 Solutions)....SoftwareMedical deviceFull timeWork at officeImmediate start
$150k - $225.5k
...at least three days a week in the office. As a Sr. Principal Lead Health Actuary Consultant , you'll manage client projects... ...existing products, tools, and pricing models in Excel, SAS, and other software with potential specialization in certain areas of health care...SoftwareMinimum wageWork at officeLocal areaRemote workFlexible hours3 days per week1 day per week$200k - $250k
...'re building the AI platform that lets medical-device and pharmaceutical teams release life-saving... ..., IP, Data Privacy, Compliance, Regulatory You won't inherit bloated processes or... ...and improving lives by making medical software safe and reliable. We empower software...SoftwareMedical deviceFull timeContract workWork at officeWorldwideMonday to Friday$80k - $200k
...across multiple sources.You will act as the lead solution architect and project driver.... ...their data needs, and designing how the software should be set up.30% Technical... ...consulting for the pharmaceutical, biotech, or medical device industriesExperience with other Veeva software...SoftwareMedical deviceWork at officeLocal areaRemote workWork from home3 days per week- ...and results-driven Head of Marketing to lead and execute global marketing initiatives... ...industries such as aerospace, automotive, medical devices, and industrial systems. Key... ...marketing strategies in the embedded systems, software development, or safety-critical domains....SoftwareMedical device
$115k - $182k
Job TitleAcoustic Engineer - Medical Device (Cambridge, MA)Job DescriptionAcoustic Engineer - Medical Device (Cambridge, MA)Contributing... ...C++ programming languages; experience with acoustic simulation software.You must be able to successfully perform the following...SoftwareMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week
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