JOB TITLE: Manager of Quality Assurance and Regulatory Affairs
REPORTS TO: President and Chief Operating Officer
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.
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.
- 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
Want to work with us? To apply, please fill out the form below and attach your cover letter and resume.