INSIGHTEC’s technology transforms the world of medicine by offering an innovative, ground-breaking non-invasive therapy platform that reduces the need for invasive surgery – COME ONBOARD
At INSIGHTEC, we value innovation, precision and operational efficiency. We are dreamers with unlimited amount of dreams, as we believe there is a chance to do something differently in almost everything that you touch. If you are passionate and share INSIGHTEC’s vision of transforming medicine as we know it, join our world class team to participate in the development of this innovative therapeutic technology.
US (Midwest/East Coast)
Service and Support Engineer
US - Midwest/East coast
- Responsible for supporting INSIGHTEC’s systems at clinical sites throughout N. America
- System troubleshooting and diagnosis of source of failures
- Preventive maintenance and repairs
- Failure, maintenance and service reporting in ERP system
- Perform system installations at new sites in the US
- 3-5 years’ experience in field service for multi-disciplinary systems
- Ability and drive for learning and work on new technology
- Organized, structured, capable working independently
- Good oral and written communication skills
- “Hands on” character
- Good interpersonal skills
- Good mechanical capabilities
- An ability to solve Hardware and Software problems dealing with variety of multivariable situations
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule
- Travel 60 – 80%, mostly US. Some international travel for training purposes
- Working hours second and third shift
Desirable Additional Skills or Experience
- B.Sc. in Electrical Engineering
“In-House” Regulatory Affairs Specialist
As a Regulatory Affairs Specialist (“RA”) with this fast growing, Class-III medical device company, you will be responsible for product submissions and registrations, license renewals, investigational device exemptions, periodic updates and registrations to regulatory agencies. As an “RA”, you will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide and with FDA and Health Canada in particular. As an “RA” you will be expected to continuously research regulatory issues and provide guidance and advice to colleagues.
As an “RA” you may also be participating in providing guidance with Process and Design controls to R&D team by ensuring the appropriate regulatory requirements, participate in ensuring regulatory compliance/conformity, in analyses of Design Verification and Validation test plans, and perform regulatory analyses of customer complaints.
Job Location and Reporting :
The job is an in-house full time position in Dallas, Texas. The position will be reporting directly to the VP Global Regulatory and CRO.
Specific Duties and Responsibilities :
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners; advise on the submission strategy.
- Write and assemble Regulatory Submissions for USA, and Canada including PMA, 510(k), pre-PMA, pre- IDE, Technical Files and Application for
- Investigational Testing for all type of devices;
- Broad experience in Clinical Trial Design, Monitoring and preparation of submissions for Clinical Studies;
- Proven ability to effectively manage multiple projects simultaneously, e.g. clinical trial management and submissions.
- Compile materials for license renewals, Device Annual reports, updates and registrations in a timely manner
Maintain regulatory files/database and chronologies in good order.
- Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Review labeling and labels for compliance with regulatory requirements
Review changes to existing products and SOPs to define the requirements for regulatory submissions
- Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes
- Participate in research of regulatory issues and dissemination of regulatory information to Production, QA/QC and R&D departments and senior management as required
- Provide guidance of the Process and Design Controls (Design and Development Planning, Design Input and Output, Design Review, Verification & Validation, Design transfer, Design changes) to the R&D core teams – As needed.
- Participate in the review of product development assuring appropriate regulatory, quality and reliability requirements are defined.
- Responsible to ensure appropriate regulatory standards are correctly established and implemented with adequate evidence of including supporting test documents.
- Participate in the review of clinical relevant test methods and Design Verification and Validation test plans, execution and reports as required
- Participate in the maintenance of technical files relevant to various external agencies and regulatory bodies.
- Ensure that all aspects of Regulatory Compliance and Quality Assurance of the DHF and other program files are met and findings are appropriately addressed in full compliance to regulations and delivery of quality product.
- Support all external/internal audits.
Required Knowledge and Skills :
- Requires a degree in engineering or related field
- 5 or more years of experience with Regulatory Submissions for USA, and Canada including PMA, 510(k), pre-PMA, pre- IDE, Technical Files and Application for Investigational testing for all type of devices
- Knowledge of USA and international medical device regulatory requirements
- Experience with FDA Class III and/or Class-II devices is mandatory
- Able to demonstrate very good regulatory writing and submissions to regulatory agencies
- Ability to foster relationships with regulatory agencies, consultants and colleagues
- Ability to support several projects simultaneously with a flexible working style and attention to detail
- Able to work independently with excellent time management skills
- Excellent work ethic with desire to be a valuable contributing team member
- Able to travel internationally
- Demonstrate excellent people skills
US Clinical Applications Specialist
The Clinical Applications Specialist drives the training program for the users of the Exablate System. The specialist is responsible for providing hands-on, didactic training, and onsite support to a clinical audience (including physicians, MR technicians, nurses etc).
• Clinical site training in the USA, including coordination and site initiation, theoretical and hands on training, treatment support, certification, and post certification site quality assurance
• Assesses potential patients from technical viewpoint to help determine treatment eligibility
• Data management (e.g. analysis, graphs, archiving)
• Review and analyze treatment results, development of updates for treatment techniques, and quality assurance methods
• Documentations and development of manuals and training material
• Data collection and analysis, preparing summaries and case reports
• Providing feedback to the system development team for future system improvements or new clinical uses
• Sales support, as needed .
• Academic degree in biomedical engineering, medical physics, medicine, biotechnology, or radiography.
• Ability to work in hospitals, outpatient clinics, research environments and MRI environment.
• Highly skilled in word, excel and power-point; experience in data analysis, preparation of presentations and clinical case review summaries.
• Candidate must be legal for employment in the US.
• This job requires travel within the US and international (up to 70% of working days).
• Working or travelling at weekends may be required.
• Knowledge in MR imaging
• Knowledge of high intensity focused ultrasound
• Knowledge in human anatomy
• Highly motivated and independent worker
• Previous experience in performing system training
Clinical Project Manager Europe Market
Reporting to: Clinical Program Manager
Location: Dallas, TX
- Manage successful execution of assigned global clinical studies in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs) as applicable to United States Food and Drug Administration (FDA) regulations, Health Canada, International Conference on Harmonization (ICH) guidelines and any other applicable guidelines and regulations.
- Responsible for clinical operational oversight and execution of assigned trial(s) in order to achieve successful delivery regarding expectations of quality, timelines,budget, and study conduct.
- Manage successful Clinical Research and Clinical Trials submissions (as needed) to Notified bodies, EU, and leading investigation centers in full compliance with local regulatory laws
- Builds and sustains extensive global networks across multiple functions at study team level
- Develop and share best practices to accelerate project timelines
- Develop professional relationships with investigational sites and key opinion leaders involved in assigned study(ies) to ensure appropriate stakeholder engagement and support.
- Manage site relationships and provides timely input to ensure that trials are executed according to agreed project plan.
- Manage internal company relationships and maintains open communication to successfully meet projected trial timelines, trial execution and completion.
- Manage study team performance and CRO subcontractors to ensure adherence to agreed deliverables within timelines.
- When applicable, manage relationships with FDA/Health Canada and/or Notified Body in EU in collaboration with the local regulatory team. Ensure full compliance with global/local regulations.
- Hands-on management of assigned clinical trials to ensure that timing of all major trial milestones meets the plan. Specifically, tracks and evaluates trial milestones and monitors overall operational performance metrics through life of the trial. Identifies issues early and proposes and tracks solutions. Whenever possible, resolves issues that have been escalated and/or take issues to management. Coordinates updates, including presentations and communications, on assigned trials to management.
- Works with internal CRO to ensure trial risk assessment is complete, and that mitigation and contingency measures are prepared and implemented. Actively assesses potential risks to trial and implements mitigation plans, as needed.
- Serves as the key point of contact for operational and process related issues and inquiries for assigned trial(s).
- Takes specific responsibility to manage quality of clinical trial initiation, execution, recruitment efforts, oversight of monitoring activities, and direct database management, and data analysis, including and not limited to successful data base lock (DBL) and reporting.
- Responsible for written regulatory/clinical communications for assigned trials, including, but limited to protocol and CRF development, responses to regulatory deficiency letters, annual reports with safety reporting, SAE/UADE reports, final Clinical Study Reports, CE Mark reports, and other internal reports as needed.
- Liaise with vendors and internal stakeholders to ensure timely data base lock is achieved
Processes & Procedures
- Manage appropriate implementation, conduct, tracking and reporting of assigned trial(s) including quality review of trial information using internal clinical trial management practices to support and manage assigned responsibilities
- Identifies and assists with opportunities for process development, improvement and implementation of policies, procedures and processes related to Good Clinical Practice, SOPs, and assigned clinical trial activities
Skills and Qualifications
- Bachelor’s degree required in medical/healthcare-related science field. Advanced degree preferred.
- Legally able to work in the U.S. and travel abroad.
- 6-8 years of regulatory / global clinical trial experience (preferably in medical device industry), with at least 2 to 3 years executing global feasibility, pivotal and/or post-approval trials.
- Preferably, some experience with PMA Class III device processes. Experiences with CE Mark, ISO, EMA or other internationalregulatory processes are welcomed.
- Demonstrates current working knowledge of all phases of clinical trial development from concept through final. Experience with electronic data capture and databases including but not limited to Oracle Clinical and Medidata
- Proficient with MS Word, Powerpoint, and Excel including data import /export management and descriptive data analysis
- Demonstrated technical competence and experience in design, implementation, tracking and completion of global clinical trials
- Knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources to achieve successful results.
- Ability to collaborate, align and manage diverse, global cross-functional matrix teams.
- Able and willing to travel as needed, including international travel.
English is a MUST.
Bilingual in Spanish or French strongly preferred.
Knowledge of global clinical trial processes and regulations (US-FDA, EU CE Mark, EMA, and Health Canada-ITA/CTA,).
Understanding of principles, implementation and maintenance of regulations.
Knowledge of global trial planning and management principles.
Demonstrates current working knowledge of all phases of clinical trial development from concept through final CSR and knowledge of operational and regulatory processes involved with clinical trials.
Clinical Research Associate
Reporting to: Senior CRA
Location: Dallas, TX
The Clinical Research Associate (CRA) position represents an opportunity to grow within an emerging medical device company. Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP/ICH) and the appropriate regulations is required. A broad understanding of essential study documentation is critical.
The CRA has broad exposure to clinical research tasks as a combination of in-house and field work. The CRA works closely with the Clinical Project Manager to support various aspects of a Clinical Trial and related regulatory activities.
Field CRA Responsibilities
• Conduct site qualification, initiation, monitoring and closeout visits and create documentation of such through accurate and detailed visit reports.
• Monitor source documents to electronic data capture system for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria
• Review all source records for patient safety and ensure complete documentation of all subject safety events (100% source document verification).
• Review regulatory binder to ensure complete, accurate, and up-to-date regulatory compliance at the site.
• Ensure compliance with protocol and overall clinical objectives.
• Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks.
• Ensure investigator involvement in the study and Institutional Review Board/Ethic Committee oversight.
• Follow through after visits to see that all outstanding requests/needs are fulfilled.
• Raise issues of significance to the appropriate level for resolution.
• Able to help site navigate informed consent issues and support Institutional Review Board approval process.
Compilation of Regulatory Submissions
• Assist in organizing documentation for regulatory submission, as needed
• Create electronic copies of submitted documents
• File all regulatory correspondence in the Regulatory Master File
• Responsible for accurate and timely maintenance of both electronic and paper files
Set up and maintenance of Regulatory Master File
• Organize site study files
• Work closely with other Company CRA’s for coverage in collecting and reviewing regulatory documentation, and assuring consistency between Regulatory Master File and site files.
• Generate and maintain study checklists as necessary and keeps accurate records of all essential study material(s).
• Responsible for accurate and timely oversight and maintenance of Regulatory Master File.
• Demonstrate expertise in understanding and managing clinical study documentation.
• Proper and timely filing of all relevant study documents and standardized filing across all studies, per applicable Standard Operating Procedures.
Required Knowledge and Skills
• Knowledge of and proficiency in spoken and written English is a MUST.
• Minimum of medical/healthcare-related University degree with basic familiarity with medical terminology
• Basic computer skills with proficiency in Microsoft Word and Excel required; PowerPoint and Database experience desirable
• Ability to foster relationships with clinical sites and colleagues
• Ability to support several projects simultaneously, a flexible working style and attention to detail are essential
• Able to work independently with excellent time management skills
• Excellent work ethic with desire to be a valuable contributing team member
• At least 3-5 years relevant industry experience in clinical research environment
• Approximately 50% travel that will vary over time, including international travel to other countries (Position requires valid passport at all times).