Senior Medical Device Regulatory Strategist
Bioethic Consulting LLC
Bioethic Consulting LLC in San Diego, CA is seeking a Senior Regulatory Affairs Specialist for medical devices to lead regulatory change assessments and U.S. submissions. The ideal candidate has 7+ years of experience in medical device regulatory affairs, with a proven ability to collaborate with Quality, Engineering, Manufacturing, R&D, and Marketing to support product approvals and lifecycle management. #J-18808-Ljbffr Bioethic Consulting LLC
- ManpowerGroup Global, Inc. is seeking a Regulatory Specialist Sr in Alameda, CA to ensure timely approval of new medical devices and continued approval of marketed products. The role includes developing regulatory strategies, guiding cross-functional teams, and advising...SeniorRegulatoryMedical device
- ...4Remote50% Remote Job Description: The Senior Quality Engineer will perform Quality Engineering... ...with quality systems and applicable regulatory standards. The role works cross-... ...experience. Proficient understanding of medical device operations and/or manufacturing...SeniorRegulatoryMedical deviceRemote work
- ...Description We are seeking a Senior Electrical Manufacturing... ...next-generation cardiovascular device from design verification through... ...with Engineering, Quality, Regulatory, Operations, Supply Chain, and... ...engineering experience in regulated medical devices. ~ Experience...SeniorRegulatoryMedical deviceContract work
$114k - $182k
Job TitleSenior/Staff Ultrasound System Engineer - Medical Device (San Diego, CA)Job DescriptionSenior/Staff Ultrasound System Engineer -... ...customer requirements into engineering specifications.quality, and regulatory teams to balance security, safety, usability, and time-to-...SeniorRegulatoryMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$132k - $172k
...science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and... ...regulatory authorities, and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).Experience supporting manufacturing process...SeniorRegulatoryMedical deviceFull timeTemporary workRemote work$118.2k - $177.2k
..., healthcare, and beyond.As a Senior Software Technical Product Manager... ...with IoT and connected device architectures, edge computing/... ...instrument platforms.Familiarity with medical device product development, risk analysis (e.g., FMEA), regulatory compliance (e.g., IEC 62304,...SeniorRegulatoryMedical deviceFull timeLocal area$143k - $215k
...physician orders a test, we ship a device directly to the patient, the... ...operational dependency, and regulatory requirement. We are building... ...the Role We are seeking a Senior UX Designer to help shape the... ...experience: Healthcare, diagnostics, medical devices, digital health,...SeniorRegulatoryMedical deviceFull timeTemporary workWork experience placementFlexible hours$30 - $35 per hour
...released in accordance with established procedures and applicable regulatory requirements. Responsibilities Serve as the facility's Change... ...and/or Document Control experience within a laboratory, medical device, or similarly regulated environment. Working knowledge of 21...SeniorRegulatoryMedical device$140.8k - $211.15k
...diabetes care. We’re hiring a Senior Software Automation Engineer... ...the design and maintenance of medical products.• Writes and... ...requirements.• Works with Quality, Regulatory, Marketing and Manufacturing... ...protocols will be a plus.• Medical device experience is preferred.•...SeniorRegulatoryMedical deviceFull timeWork experience placementWork at office$140k - $200k
...safety-critical systems. Senior R & D Engineer, Electrical Engineering... ...of Synchron’s implantable devices. This individual will serve... ...-case circuit analysis Regulatory & Design Controls • Serve as... ...Qualifications • Active implantable medical device experience (e.g.,...SeniorRegulatoryMedical deviceFull timeContract workTemporary workInternshipFlexible hours$155k - $185k
...more information, visit . Job summaryThe Senior Embedded Software Engineer is... ...for electroporation and drug delivery medical devices. This role focuses on embedded C++ development... ...systems, electrical, mechanical, quality, regulatory, and cybersecurity teamsParticipate in...SeniorRegulatoryMedical deviceFull timeTemporary work$100k - $200k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...scientists.The OpportunityThe position of Senior Database Engineer II is within our Infectious... ...understanding of relevant legal and regulatory requirements, such as SOX, PCI, HIPAA,...SeniorRegulatoryMedical deviceWorldwideShift work$114k - $182k
JOB DESCRIPTION Job Title Senior/Staff Electrical Engineer – Medical Device (San Diego, CA) Job Description Senior/Staff Electrical Engineer... ...validation plans in collaboration with Quality and Regulatory teams, actively participating in transferring...SeniorRegulatoryMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...when you wake. We're a venture-backed medical device startup that makes the world’s smallest... ...Yours™. The Role We are hiring a Senior Quality Engineer to coordinate,... ...QMS) and to ensure commitments tied to regulatory and quality requirements are met. You will...SeniorRegulatoryMedical deviceWork at officeNight shift
$140k - $160k
...safety-critical systems. Senior R & D Engineer, Mechanical/... ...s mechanical design, driving device performance, deliverability,... ...role requiring fluency across medical device design, neurovascular... ...Experience supporting IDE or PMA regulatory submissions for Class III...SeniorRegulatoryMedical deviceFull timeTemporary workInternshipFlexible hours- ...delivers rapid testing and point-of-care medical device solutions used in the detection of... ...questions in healthcare. Position: Senior BD Manager Location: Onsite - San Diego... ...Work with internal stakeholders in Regulatory, Finance, and Operations to support deal...SeniorRegulatoryMedical deviceContract workFlexible hoursShift work
- ...delivers rapid testing and point-of-care medical device solutions used in the detection of... ...Job Type: Full time Job Title: Senior Project Manager Location: Onsite - San... ...maintaining alignment with company strategy and regulatory requirements. The ideal candidate will...SeniorRegulatoryMedical deviceFull timeFlexible hoursShift work
$210k - $240k
...real-world, safety-critical systems. Senior Director, Regulatory Affairs Location: San Diego,... ...regulatory strategy for complex BCI devices, including AI/ML considerations, software... ...software- and firmware-driven medical technologies Ensure ongoing compliance...SeniorRegulatoryMedical deviceFull timeTemporary workInternshipFlexible hours$130k - $165k
...Bionics Beta Bionics, Inc. is a medical technology company dedicated... ...We are seeking a Senior Android Software Engineer to... ...integral part of our medical device ecosystem. In this role,... ...engineering, cybersecurity, quality, regulatory, product, and clinical teams...SeniorRegulatoryMedical deviceFull timeWork at officeLocal area$130k - $150k
...real-world, safety-critical systems. Senior Quality Engineer (New Product... ...with R&D, Systems Engineering, Clinical, Regulatory Affairs, Manufacturing Engineering, and... ...Engineering experience in an FDA-regulated medical device environment with demonstrated experience...SeniorRegulatoryMedical deviceFull timeContract workTemporary workInternshipFlexible hours$140k - $200k
...safety-critical systems. Senior Engineer, Embedded Software /... ...mechanisms suitable for implantable devices • Establish system-level... ...pivotal trial milestones Regulatory & Design Controls • Serve as... ...Qualifications • Implantable medical device experience • Neural...SeniorRegulatoryMedical deviceFull timeTemporary workInternshipFlexible hours$130k - $150k
...safety-critical systems. Senior Quality Engineer (Operations)... ...in compliance with applicable regulatory requirements. You will partner... ...Inspection Procedures, DHRs, Device Master Records (DMRs), and... ...experience in an FDA-regulated medical device environment, with hands...SeniorRegulatoryMedical deviceFull timeContract workTemporary workInternshipFlexible hoursShift work$91.7k - $137.53k
Job SummaryPosition Overview: The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international... ...: • Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets. Provide regulatory...SeniorRegulatoryMedical deviceFull timeWork at office- ...Job Description Job Description Senior Mechanical Engineer – Medical Device San Diego, CA (Onsite) 130,000-180,000 DOE Join a growing medical... ...’ll work closely with systems, electrical, quality, regulatory, operations, and lab teams to improve product...SeniorRegulatoryMedical deviceLocal areaRelocation
$108.03k - $140k
...countries and regions.Grifols Diagnostic Solutions is seeking a Senior Quality Assurance Specialist. The Sr Quality Assurance... ...standardize the investigation process.Applies knowledge of medical device regulatory requirements to identify reportable events as they are received...SeniorRegulatoryMedical device$154.4k - $231.58k
...marketing strategies. Reporting to the Senior Director of Product Marketing, the... ...Regional Downstream Consumer Marketing, Medical Affairs, Regulatory, Legal, and other stakeholders.Drive alignment... ...and execution, ideally within medical device, pharmaceutical and/or diabetes...SeniorRegulatoryMedical deviceFull timeWork at officeRemote workFlexible hours$205.1k - $307.7k
...AI-driven applications, the regulatory and quality requirements governing... ...as those governing physical devices. IEC 62304 compliance, SaMD... ...products and software-driven medical devices across Illumina's... ...and PMS functionOperate as a senior quality leader Serve as the subject...SeniorRegulatoryMedical deviceFull timeLocal area- ...1 CFR part 11, internal SOPs and training, and international regulatory requirements. Plays an active role in taking project solutions... ...within pharmaceutical or related industry (biotechnology, medical device, Clinical Research Organization (CRO)). SAS Certified Base and...SeniorRegulatoryMedical device
$116k - $145k
Yoh is seeking a Senior Supplier Quality Engineer for our client in San Diego. In this... ...molding and plastics. Industry: Medical Device ManufacturingLocation: OnsiteCompensation... ...organization.Host third-party audits conducted by regulatory agencies, notified bodies, and business...SeniorRegulatoryMedical deviceWork at office$114k - $137k
...validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr.... ...~7–11 years of experience in the biotech, pharmaceutical, or medical device industry. ~ Strong knowledge of FDA cGMP requirements, FMEA...SeniorRegulatoryMedical deviceWork at officeRemote workWork visaFlexible hours
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