Senior Medical Device Investigation Analyst (SaMD & MDR)
Scorpion Therapeutics
Takeda is seeking a qualified candidate to lead investigations for medical device software and connected devices, ensuring compliance with FDA Quality System Regulations and MDR. The role involves managing complaint intake, conducting FDA-ready root cause analyses, and collaborating with Regulatory and Quality teams. The position requires experience in regulated medical device investigations, SQL skills, and strong communication. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Medical Device Investigation Analyst (SaMD & MDR) in Exton, PA vacancy
- Role Lead investigations for medical device software and connected medical devices within Takeda's Plasma-Derived... ...FDA Quality System Regulations and MDR. Responsibilities manage complaint... ...making skills Preferred experience with SaMD, digital health, plasma collection,...Medical deviceFull time
$89.9k - $141.24k
...Description: About the Role: The DD&T US Medical Device Investigation Analyst, reporting to the Plasma-Derived... ...Regulations and Medical Device Reporting (MDR) requirements. Working closely with... ...with software as a medical device (SaMD) or digital health platforms. Familiarity...Medical deviceMinimum wageFull timeLocal areaImmediate start- ...in Bannockburn, IL / Exton, PA currently seeks a DD&T US Medical Device Investigation Analyst to lead investigations related to software devices used within... ...operations in the US. You will coordinate FDA QSR and MDR-compliant investigations and prepare defensible records...Medical device
- ...detections that generate actionable leads for investigative teams.Establishes performance measures... ..., risk partners, technology teams, and senior leadership.Reviews analytical approaches and work products developed by other analysts and provides technical direction,...SeniorFull time
- Join Vanguard’s Fixed Income team as a Senior Quantitative MBS Research Analyst, where your quantitative expertise, market knowledge, and ability to... ...income investment outcomes for the active Agency MBS desk.Investigates machine learning techniques and alternative data...SeniorFull timeWork experience placement
- ...Life Sciences (Pharmaceuticals, Bio-Tech, Medical Devices) industry background experience is Required # Job Description (at least key/priority job requirements): Looking for BAs experienced in the Planning space, who can work with the business on scope...Medical device
- ...one compliance manager and one privacy senior manager.Execute appropriate compliance... ...'s policies.Help oversee internal investigations across global operations into potential... ...experience working in pharmaceutical, medical device, biotech or manufacturing industries.Strong...SeniorMedical deviceWork at officeFlexible hours
- ...sustainability efforts. Job SummaryThe Senior Specialist, Regulatory... ...West’s global portfolio of medical devices, combination products,... ...premarket submissions (510(k)), EU MDR Technical Documentation, Master... ...device, combination product, SaMD/software-enabled device, and...SeniorMedical deviceContract workTemporary workWork at office3 days per week
- ...our sustainability efforts. Job SummaryThe Senior Specialist, Regulatory Affairs is expected to understand development of medical devices as applicable to combination products. To... ...regulations (Title 21), EU MDD (93/42/EEC) and MDR (2017/745), 21 CFR 820, 210, 211 and ISO 1...SeniorMedical deviceTemporary workWork at officeWorldwideRelocationFlexible hours
- ...SME input to ensure all Out-of-Specification and Laboratory Investigation issues are investigated and resolved in a timely manner.... ...experience in Analytical Sciences within the pharmaceutical and/or medical device industries, combination products, peptides, small molecules,...SeniorMedical deviceFull timeContract workWork at office
- Position Title:Senior Compensation SpecialistDepartment: Human Resources / Total RewardsReports To: Director, Global Compensation Location: Hybrid - Exton, PAPosition Type: Full-TimePosition SummaryThe Senior Compensation Specialist plays a role in the implementation,...Senior
- ...sustainability efforts. Job Summary The Senior Manager, Human Resources Business... ...including conducting thorough and objective investigations. Lead talent assessment and succession... ...Experience in Pharmaceutical, Medical Device or Manufacturing industries preferred....SeniorMedical deviceWork experience placementWork at officeLocal area3 days per week
- Risk Advisory Analyst, Senior Specialist:Provide operational and strategic risk guidance, oversight, and independent challenge to Personal Wealth leaders and enterprise partners, consistent with Vanguard's risk management framework.Identify, assess, and prioritize existing...SeniorFull timeWork experience placement
- Senior Manager SAP QM, Functional Design & Architect Requisition ID: 75178 Date: Sep... .... Experience in pharmaceutical, medical device, life sciences, biotechnology, or other... ..., knowledge management, and root-cause investigation support. Collaborate with data and analytics...SeniorMedical deviceLocal areaRelocation3 days per week
- ...Operating at the heart of a complex fiduciary environment—anchored in ERISA and aligned with IRS and DOL requirements—we’re seeking a Senior Divisional Risk Advisor to shape and elevate our risk strategy.In this role, you’ll bring deep ERISA expertise to guide business...SeniorFull timeWork experience placement
- ...Analytics team is expanding! We are seeking an experienced data analyst to support the Flagship Client segment and the Distribution... ...visualizationsTranslate analysis into clear, actionable recommendations for senior leadersAnalytics Product OwnershipDesign, develop, and manage...SeniorFull time
- West is seeking a HR Total Rewards Benefits professional to administer the U.S. Retirement programs (401(k), Non-Qualified Plans) and manage daily plan operations. You will partner with vendors, auditors, and payroll to ensure accurate data and timely communications. You...Senior
- Automated Financial Systems, LLC is seeking a Senior Analyst, Enterprise Performance to design and own the company-wide performance framework. You will partner with the ELT to define what should be measured, build systems to capture it, and deliver intelligence to help...Senior
- ...Request ID: 108190-1 Title: Senior Data Analyst Location: Malvern, PA (Onsite) Duration: 6 months Pay Range: $55 - $60/Hour on W2/C2C (All inclusive) JOB DESCRIPTION: Key Duties & Responsibilities: Collect, clean, and organize structured...SeniorLocal area
$79k - $127.65k
...talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Senior Offer Development Analyst, US Orthopedics. The preference is to be based in one of the following locations: Raynham, MA, Raritan, NJ, Warsaw, IN...SeniorFull timeContract workWork experience placementWork at officeLocal areaImmediate start- ...Treasury & Tax Recruitment Specialist Position Overview: The Senior Cash & Reconciliation Analyst will oversee the end-to-end payment process, monitor... ...records to identify and resolve discrepancies Investigate discrepancies in collaboration with preparers and cash...SeniorFull time
- ...leading retail brands - QVC, HSN, Ballard Designs, Frontgate, Garnet Hill and Grandin RoadYour Opportunity, Your TeamThe Senior Operations Business Analyst supports QVC and drives data-informed decision-making across operations and supply chain functions by analyzing...SeniorFull timeLocal areaRelocation package
$58 - $60 per hour
...Requisition ID: 107606-1 Title: Business Analyst Duration: 6-12 months with possible extension Location: Malvern PA (F2F interview) Salary Range: $58- $60 an hour on W2/C2C Job Description: Business Analysis Gather and document business requirements...SeniorLocal area- ...leading retail brands - QVC, HSN, Ballard Designs, Frontgate, Garnet Hill and Grandin RoadYour Opportunity, Your TeamThe Senior Operations Business Analyst supports QVC and leads complex enterprise-level analysis, develops executive-ready insights and tools, drives cross-...SeniorHourly payFull timeLocal areaRelocation package
- ...regulatory programs across West’s portfolio of medical devices, combination products, and packaging/... ...such as Premarket Notifications, EU MDR Technical Documentation, and Master... ...including change controls, device complaint investigations, CAPAs, and post-market surveillance....Medical deviceTemporary workRelocationVisa sponsorshipFlexible hours3 days per week
- ...Sr. Business Analyst Client: Omni Cable Location: West Chester, PA (3 days’ on-site; 2 days’ remote) Duration: 1 Year+ Contract Interview Process: ~1st Step: Video Interview ~2nd Step: On-Site Interview in West Chester, PA Notes: ~ Please...SeniorContract workRemote work
- ...PennsylvaniaOnsiteFull Time$150k - $165kWe are partnered with a leading medical device company that develops innovative technologies for spinal,... ...joint reconstruction procedures. They are looking to hire a Senior Firmware Engineer to join their Spinal team, developing next-...SeniorMedical device
- ...view of how all areas of the business are actually performing — and the analytical capability to turn that data into action. The Senior Analyst, Enterprise Performance designs and owns AFS’s performance measurement framework — partnering with the ELT to define what...Senior
- ...experience Preferred Knowledge, Skills and AbilitiesExcellent interpersonal, communication and listening skills.Experience in medical device regulatory affairs and/or design control process, direct interactions with regulatory agencies and management of regulatory support...SeniorMedical deviceContract workLocal area3 days per week
- The QC Senior Scientist - Microbiology is responsible for Test... ...duties, mentors and trains other analysts, supports product regulatory... ...in and/or lead laboratory investigations, deviations, and assay... ...pharmaceutical, biotechnology, medical device, or healthcare environment.Experience...SeniorMedical deviceFull timeLocal areaShift workWeekend work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Medical Device Investigation Analyst (SaMD & MDR). Be the first to apply!
Related searches
- recruiting analyst Exton, PA
- integration analyst Exton, PA
- ecommerce analyst Exton, PA
- health program analyst Exton, PA
- data loss prevention analyst Exton, PA
- underwriting analyst Exton, PA
- chargeback analyst Exton, PA
- advertising analyst Exton, PA
- hedge fund analyst Exton, PA
- credentialing analyst Exton, PA


