Source Job

Continental US

  • Represent the reviewer's perspective across our document intelligence platform, ensuring alerts and workflows provide genuine value.
  • Lead discovery and validation sessions, translating reviewer needs into workflows, user stories, and acceptance criteria.
  • Test completed capabilities from a reviewer's perspective to identify missing requirements and workflow gaps.

Regulatory Affairs Requirements Gathering

20 jobs similar to Medical Device Workflow & Validation Lead

Jobs ranked by similarity.

US

  • Perform medical reviews and utilization management to determine medical necessity for services and appeals.
  • Evaluate medical records and document decisions using clinical guidelines and protocol sets.
  • Educate members, providers, and staff on coverage determinations, medical terminology, and coding procedures.

Palmetto GBA is a healthcare administrator and one of the nation's largest medical claims processors. As part of BlueCross BlueShield of South Carolina, we've served clients for 70+ years and offer training and tuition assistance.

US

  • Perform concurrent medical record reviews on nursing units to clarify patient documentation.
  • Prompt physicians to resolve missing, unclear, or conflicting documentation for appropriate reimbursement.
  • Provide education to patient care providers on clinical documentation standards and coding requirements.

Virginia Mason Franciscan Health provides a full spectrum of health care services across the Puget Sound region, with a legacy of compassionate care and innovation. With 10 hospitals and nearly 300 care sites, the organization is dedicated to healing the whole person through rigorous research, education, and collaboration.

US

  • Manage submission workflows to ensure timely peer review and resolve vendor or colleague queries professionally.
  • Troubleshoot manuscript and system issues, proactively raising data-driven recommendations for process improvements.
  • Serve as daily liaison with vendors, monitoring performance against KPIs and contributing to operational projects.

PLOS is a catalyst in open science, reimagining models to meet open science principles and removing barriers in knowledge sharing. The organization is supported by a global in-house team and values diverse perspectives to create a more equitable system of scientific knowledge.

$130,100–$207,900/yr
US

  • Lead technical implementation of Intuitive's digital solutions across hospital systems, acting as a trusted advisor for regional IDNs and hospitals.
  • Drive digital activation excellence by engaging with technical review boards, delivering clear technical presentations, and ensuring smooth go-live.
  • Support post-go-live adoption and relay field learnings to leadership to influence the product roadmap.

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, creating technologies like the da Vinci surgical system. They are a team of engineers, clinicians, and innovators united to make surgery smarter, safer, and more human, with a challenging but deeply meaningful work culture.

$160,000–$183,000/yr
US

  • Drive the definition and execution of next-generation medical devices that meet user needs, clinical requirements, and regulatory expectations.
  • Own product requirements, user needs, and product roadmaps while ensuring alignment between customer needs and engineering execution.
  • Lead cross-functional product planning from concept through commercialization, balancing user experience, technical feasibility, and schedule.

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. They are a growing company with offices in Paris, Boston, New York, and the San Francisco Bay Area, fostering a collaborative and remote-friendly culture.

$137,300–$242,300/yr
US

  • Lead clinical study strategy and execution for regulatory approvals and evidence initiatives.
  • Partner with stakeholders, investigators, and KOLs to design protocols and manage study progress.
  • Oversee monitoring, compliance, and data analysis while mentoring junior staff.

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for da Vinci and Ion systems. Its team of engineers, clinicians, and innovators works to make surgery smarter, safer, and more human.

US

  • Monitor inventory for cardiac and pulmonary rehab devices, ensuring adequate stock levels across programs.
  • Serve as the point of contact for patients experiencing lost items, damaged items, delivery delays, or billing issues.
  • Investigate and resolve delivery and shipping issues in coordination with carrier partners and warehouse ops.

Carda Health is building the world's first patient-centered virtual heart and lung platform, starting with cardiac and pulmonary rehab. Backed by top investors, we are a team of clinicians, mathematicians, entrepreneurs, and engineers using technology and data to transform healthcare.

$120,000–$140,000/yr
US

  • Lead complex client implementations, from customer use cases to success metrics and clinical workflows.
  • Train and educate customers on BioIntelliSense product offerings and value proposition.
  • Provide ongoing clinical support and post-implementation optimization while coordinating across teams.

BioIntelliSense is a healthcare technology company providing FDA-cleared wearable monitors, like the BioButton, and AI-driven analytics for early detection of patient decline. The company has a remote-first culture with a global team and offices in Colorado and California.

US

  • Lead the development and launch of Revecore's DRGV service offering, expanding Billing and Coding Optimization capabilities.
  • Define operating models, workflows, staffing, productivity metrics, and quality standards to scale the service line.
  • Partner cross-functionally with Product, Data, AI, and Operations to translate DRGV requirements into scalable technology solutions.

Revecore helps hospitals recover revenue they've earned through specialized expertise and proprietary technology. Trusted by more than 1,300 hospitals across 48 states, the company fosters a supportive, innovative workplace where employees are trusted to do their best work.

$146,100–$182,600/yr
US

  • Develops and drives regulatory strategy for FDA Pharma and IVDR initiatives.
  • Represents the regulatory function on cross-functional teams and interacts with regulatory authorities.
  • Coordinates regulatory submissions and ensures compliance with global requirements.

Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.

$110,000–$140,000/yr
US

  • Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
  • Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
  • Develop and maintain digital/software components of quality management systems, including AI quality management systems.

Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.

US

  • Oversee delegated audits related to UM, Credentialing, Claims, Enrollment, and Appeals processes to ensure compliance with payer contracts.
  • Educate staff, update policies and workflows, and act as a liaison between payers and local market leadership during audits.
  • Operationalize regulatory communications from governing bodies and document process changes for upstream and downstream teams.

Dignity Health Management Services offers integrated management and business services to healthcare providers, focusing on managed care administrative and clinical services to contain costs and improve quality. It is part of CommonSpirit Health, a large health system with a mission-driven culture centered on community and patient care.

Europe

  • Provide consulting and education for Intuitive technology and reprocessing best practices.
  • Manage territory and partner with hospitals to sustain da Vinci and Ion programs.
  • Support customer engagements, events, and reporting; act as a Medical Device Consultant.

Intuitive is a pioneer in robotic-assisted surgery, advancing minimally invasive care through intelligent technology. For over 25 years, the company has fostered an inclusive culture where diverse teams work together to solve healthcare challenges.

India

  • Secure regulatory approvals for innovative medical devices in the Indian market.
  • Collaborate with global regulatory teams on submissions, documentation, and compliance.
  • Interpret local regulations and support BIS certification and import/export requirements.

The company develops innovative medical devices and operates in a global healthcare technology environment. It values regulatory compliance, cross-functional collaboration, and professional growth, with a remote-friendly and internationally connected culture.

US

  • Serve as a technical lead and device subject matter resource across the medical device total product life cycle.
  • Analyze premarket and postmarket submissions, evaluating safety, effectiveness, and benefit-risk determinations.
  • Develop SOPs, real-world evidence protocols, and risk standards grounded in FDA guidance while mentoring junior engineers.

ICA, Inc. is a rapidly growing government consulting firm providing innovative solutions in public health research, advanced data science, and strategic services. Our small but collaborative team prioritizes work-life balance and supports dynamic, highly skilled professionals.

  • Perform on-site or remote pre-study, initiation, interim, and close-out monitoring visits to ensure adequate facilities and staff.
  • Identify investigators and verify qualifications, resources, and staff for conducting clinical studies.
  • Train investigational site staff and support regulatory submissions as applicable.

Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. With a collaborative international team across North America, South America, Europe, Asia, and Australia, the company values teamwork, flexibility, and work-life balance.

$30–$37/hr
US

  • Supervise and train the credentialing associate team to ensure high performance.
  • Document and refine insurance credentialing workflows and processes.
  • Collaborate with the Credentialing Team Lead and partners to monitor metrics and resolve issues.

BetterHelp is the world's largest online therapy service, connecting millions of people with licensed therapists to make mental healthcare more accessible. As part of Teladoc Health, it offers startup energy with the support of a large company and a diverse, collaborative culture.

Europe

  • Drive SimNow 2 simulator implementations and upgrades, coordinating cross-functional activities.
  • Interface between customer IT/OR staff and Intuitive service teams to schedule and execute upgrades.
  • Ensure documentation and clear status/risk communication to stakeholders and EU leadership.

Intuitive is a pioneer in robotic-assisted surgery, expanding physicians' potential to heal through intelligent technology. With a diverse, inclusive team of over 25 years, we work globally to solve healthcare's hardest challenges.

$132,000–$223,500/yr
US

  • Provide expert clinical and technical support to physicians and staff during robotic surgery procedures.
  • Assist new users in navigating the learning curve and achieving proficiency with Intuitive systems.
  • Collaborate with global teams to share best practices and drive product improvements.

We are a global leader in robotic-assisted surgery and minimally invasive care, with technologies like the da Vinci system transforming care for millions of patients. We are a team of engineers, clinicians, and innovators united to make surgery smarter, safer, and more human.

$84,000–$126,000/yr
US

  • Conduct medical necessity reviews and continued stay reviews using approved clinical criteria to support quality and financial outcomes.
  • Collaborate with liaisons, physicians, and revenue cycle teams to manage denials, appeals, and appropriate levels of care.
  • Maintain documentation, monitor utilization trends, and facilitate patient care planning across the care team.

Ensemble is a leading provider of technology-enabled revenue cycle management solutions for health systems, including hospitals and affiliated physician groups. They empower associates to challenge the status quo and put people first, fostering a collaborative and innovative culture.