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JOB TITLE:  Manager of Quality Assurance and Regulatory Affairs

REPORTS TO:  President and Chief Operating Officer

 

COMPANY OVERVIEW

This is a unique opportunity to join a company that is leveraging its long history of success in launching a disruptive technology that is revolutionizing the way that medical images are viewed and shared. NucleusHealth is an innovative teleradiology service provider and medical imaging technology company. Our technology is focused on cloud-based medical image management and interpretation that advances patient care by facilitating a global image exchange accessible by patients, physicians and health care networks. The company offers award-winning teleradiology services through StatRad and SaaS and PaaS technology licensing through Nucleus.io.

 

POSITION OVERVIEW

The Manager, Quality Assurance and Regulatory owns the Quality Management System and is responsible for ensuring compliance to applicable regulations and standards throughout the organization, as well as acting as the Official Correspondent with regulatory agencies.

 

PRIMARY RESPONSIBILITIES 

  • Management Representative – Ensures that quality management system requirements are effectively established and maintained; reports to top management on the performance of the quality management system; ensures the promotion of awareness of regulatory requirements throughout the organization.
  • Official Correspondent – Serves as a point of contact with FDA on matters relating to the registration of device establishments and the listing of device products.
  • Develops and maintains Quality System processes and tools in compliance with 21 CFR 820, ISO 13485, ISO 27001, HIPAA, JCAHO, and other relevant regulations, standards, and requirements.
  • Collaborates with IT and Engineering to establish, validate, and maintain tools for automating quality system processes, as appropriate.
  • Hosts audits and inspections; manages the internal audit process.
  • Advises executive management on creation of Corrective and Preventive Actions; manages the CAPA process and records.
  • Reviews complaints and determines required actions in collaboration with Customer Service. Submits Medical Device/Vigilance reports as appropriate.
  • Prepares product registration submissions. Obtains domestic and international regulatory clearances, approvals, registrations and licenses for new and existing medical devices.
  • Reviews and approves engineering changes, advertising, promotional items and labeling for regulatory compliance.
  • Advises internal stakeholders regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
  • Ensures products are developed per the requirements of the Product Development Procedure and related processes. Participates in design reviews.
  • Reviews customer support tickets and bugs for impact to the established risk assessment
  • Develops and maintains the hazard analysis and risk analysis in collaboration with Engineering.
  • Develops product manuals and other technical communications.

 

JOB REQUIREMENTS AND SKILLS 

  • Detailed knowledge of medical device regulations and other global laws, regulations, and standards including 21CFR 820, ISO 13485, ISO27001, ISO14971, etc.
  • Must have personal experience with successful preparation and submission of 510(k) submissions.
  • Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
  • Strong background in Design Controls.
  • Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
  • Working knowledge of Hospital PACS technology and other radiology systems is preferred.

 

EDUCATION AND EXPERIENCE

  • College degree required in engineering, biomedical science, or related at Bachelor level
  • Minimum of 5 years of experience in the medical device industry within the Quality Assurance and/or Regulatory Affairs disciplines.

 

WORK LOCATION AND CONDITIONS 

  • Corporate office in San Diego, CA
  • Full time, Exempt (or Non-Exempt) position
  • Occasional travel
Filter by location: All San Diego
Full-Time

Credentialing and Licensing Assistant

San Diego / Corporate Office

Full-Time

JOB TITLE:        Credentialing and Licensing Assistant

 

REPORTS TO:    Manager of Credentialing and Licensing Operations

 

COMPANY OVERVIEW

This is a unique opportunity to join a company that is leveraging a long history of success in the medical image industry. For 20 years NucleusHealth (formerly known as StatRad) has provided high quality interpretation of medical images through its award winning teleradiology services, and along the way developed innovate technologies to ensure images and services are delivered with unsurpassed speed, security, and quality. NucleusHealth’s latest web based technology is revolutionizing the industry by providing a fundamentally new way for the ingestion, delivery, transfer and storage of medical images. Our goal is to facilitate a global medical image exchange accessible by patients, physicians, and healthcare networks. The company offers its software as a service (SaaS) and as a platform (PaaS).

 

POSITION OVERVIEW

The Credentialing/Administrative Assistant assists the Director of Credentialing and Licensing in all aspects of licensing and credentialing NucleusHealth radiologists, on behalf of NucleusHealth and its clients, which are located across the country.  The Credentialing/Administrative Assistant works hand-in-hand with their director and department colleagues, as well as with the other areas of the company.

 

PRIMARY RESPONSIBILITIES 

  • Work as a liaison to communicate effectively with physicians, hospitals, and clients
  • Enter and assist with gathering information for radiologists needed to respond to Quality Assurance and Peer Review
  • Track and update billing go-backs for StatRad radiologists on behalf of client
  • Ensure staff access to hospital systems is kept current
  • Create hospital accounts in proprietary Admin system
  • Assist Implementation Specialist with setting up new hospitals during implementation
  • Compose monthly statistical reports for clients, often using Microsoft Excel
  • Conduct investigations on studies that fall out of the standard
  • Ensure state, federal and HIPPA compliance regulations are being met
  • Maintain and demonstrate continuing product knowledge as it relates to the technical application of teleradiology
  • Operate standard office equipment efficiently to include multi-line telephone system, facsimile machine, photocopy machine, postage meter, calculator and computer/printer/scanner

 

REQUIREMENTS

  • Bachelor’s Degree
  • Credentialing experience preferred, but not required
  • Office equipment (phone, fax, etc.) and computer proficiency necessary, including Microsoft Office (Outlook, Word, Excel, PowerPoint) and Adobe
  • Must be able to learn quickly and work with minimal supervision
  • Ability to effectively prioritize and execute tasks in a high-volume, high-pressure environment
  • Strong customer service orientation and focus
  • Must be reliable and possess extreme attention to detail and documentation
  • Excellent interpersonal and communication skills, both oral and written

 

WORK LOCATION AND CONDITIONS

  • Corporate office in San Diego
  • Full time, non-exempt position, with some overtime required
Filter by location: All San Diego
Full-Time

Credentialing and Licensing Assistant

San Diego / Corporate Office

Full-Time