What are the responsibilities and job description for the Director of Quality & Regulatory position at Imperative Care?
SUMMARY:
Kandu Health is developing a novel and exciting digital health platform that empowers, supports, and connects those affected by stroke. We are founded and led by experienced healthcare leaders, clinical advisors, and technology experts with a deep understanding of this large and important space. As a subsidiary of Imperative Care, Kandu Health offers the full benefits of a Series-D funded company, with the excitement and innovation of a startup. Join us and help build the first-of-its-kind digital platform supporting stroke survivors and their families.
We are looking for an exceptional Director of Quality and Regulatory to join the team and align business and technology strategies to drive the success of this disruptive startup in the HealthTech space.
Location – Bay Area, this position is currently 100% remote
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
- Directs the implementation and maintenance of the Quality Management System (QMS) to positively impact design, development, production, installation, and service of products
- Fosters a culture of quality to ensure that compliance to FDA regulations, ISO standards, and company procedures is a fundamental business practice
- Provide clear regulatory guidelines regarding local regulatory environment requirements to company personnel
- Develop quality and regulatory strategies and objectives for new and sustaining product development projects to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards
- Manages relationships with the regulatory agencies ensuring a common vision and best practices approach to compliance
- Directs the internal audit and continuous improvement programs, driving timely & effective management of product quality and compliance issues
- Establish and lead periodic management reviews of the QMS (people, processes, tools, and training), ensuring the QMS is adequate, effective and suitable
- Leads the complaint handling and post-market surveillance unit to effectively investigate and resolve customer issues, including regulatory reporting as appropriate
- Oversees personnel conducting product testing for compliance with applicable quality standards and specifications
- Assesses the suitability of potential and existing suppliers to meet current company needs
- Reviews engineering documentation for clarity, accuracy, testability, manufacturability, reliability, and risk
- Maintain ongoing awareness of all job responsibilities as required by the company’s quality management system
- Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy
- Good communication and collaboration skills at all levels.
- Proactive, can-do attitude
- Data-driven with strong data analysis and evaluation skills.
- A problem solver, able to seek out and identify the root causes of issues
EDUCATION/EXPERIENCE:
- Bachelor’s degree in Engineering, or other related Science/Engineering field
- Ten or more years of relevant work experience in a highly regulated industry (medical device, aerospace, etc.)
- Proven effective experience in regulatory work and interacting with regulatory authorities including a track record of successful regulatory submissions both in the United States and globally
- Experience with QSR, ISO 14971, ISO 13485, IEC standards
- Experience with software submissions (experience with cloud-based products a plus)
- Strong written and verbal communication skills across all levels of the organization
- Excellent organization and time management skills to support multiple simultaneous projects
PREFERRED QUALIFICATIONS:
- Quality-related certifications preferred (ASQ, AAMI, Six Sigma, etc.)
SUPERVISORY RESPONSIBILITIES:
May supervise junior-level staff as the Quality and Regulatory function grows.
