Head of Quality and Regulatory

Vave Health

Santa Clara, CA, US / Redmond, WA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 01/15/2021
  • Website: vavehealth.com
  • Company Address: 585 Broadway, Redwood City, CA, 94063

About Vave Health

We are an early-stage, stealth startup in the digital health space.

Job Description

COMPANY INFORMATION:
 
Vave Health is a healthcare technology startup based in the Bay Area. Our mission is to provide the world with connected and personal tools that will help deliver better care, improve patient experience, and drive healthcare efficiency.  Our next generation wireless ultrasound solution enables faster diagnosis and treatment at the point of care resulting in better patient outcomes.
 
Vave Health is pushing the boundaries of innovation in healthcare to make the world a healthier place. We believe that by working passionately in concert with clinicians and other creators, we will bring the most efficient and effective products to the medical field.  Our drive for excellence propels us to the forefront of medical technology and digital health. 
 
As the Head of Quality and Regulatory, you will own all development and management of Vave Health’s quality management systems by setting quality goals, performing audits, and improving all aspects of our quality system. This includes submissions, operations, on-boarding, and taking the lead with Global FDA product approvals.  
 
This person will also be responsible for production controls, performance, customer experience, design controls, risk management, and quality management governance. 
 
If you’re passionate about building out all functions of Quality Assurance and Regulatory, you’ll love working with us at Vave Health!

WHAT YOU’LL DO

    • Demonstrate yourself as an effective and collaborative leader to drive our medical device/digital health company’s quality and regulatory efforts.
    • You will own Quality Assurance to ensure our products meet applicable quality and regulatory requirements, including supporting our customers with HIPPA compliance.
    • Have the autonomy to create a Quality Management System that includes risk management assessments, validation testing, resource definition and test methodologies.
    • You’ll lead project execution while working with product managers, development teams and content experts to meet deadlines and work with our ISO and FDA 510(k) and other county regulatory submissions.

REQUIREMENTS

    • You’ll need a minimum of 10 years’ experience in regulatory affairs and quality assurance, along with a deep understanding of the medical device and digital health industry.
    • You must be comfortable providing regulatory guidance, insights, and training to Vave Health staff on applicable FDA guidance, ISO 13485 standards, and regionally required licensing, certifications and/or registrations; regulatory surveillance audits; regulatory submissions or registrations (US and internationally); risk management, post-market notifications, advisory notices, field actions, and recalls.
    • Work as a direct liaison with global notified bodies (US FDA, Health Canada, EU, etc.), managing relationships to ensure all inquiries and requests are carefully handled.
    • Tirelessly shape regional and global regulatory guidance and standards while providing critical regulatory input in all medical device development activities.
    • Expertise in design and development planning, risk and hazards analysis, testing schemes, usability and human factor testing, verification, analytical, and clinical validations.
    • You’ll be comfortable with providing guidance on new product evaluations, drawing on expertise submitting to and working with governing bodies.
    • You’ll be the point of contact for internal and external audits.
    • Experience with leading FDA 510(k) and IDE submissions.
    • Experience with Medical Device Product Development, Requirement Gathering, Risk Management, and Design Control.
COMPENSATION:
 
The position will receive an attractive package of stock options, base salary, and bonus.
 
Vave Health is committed to equal employment opportunity. The company offers a drug-free work environment to all qualified applicants without regard to race, religion, color, sex, age, national origin, sexual orientation, disability, marital status, veteran status or any other category protected by applicable law. Equal employment opportunity includes hiring, training, promotion, transfer, demotions and termination.

Related Jobs

Senior Embedded Software Engineer

Vave Health - Santa Clara, CA, USRedmond, WA, US

Staff Ultrasound Engineer

Vave Health - Santa Clara, CA, USRedmond, WA, US

Senior Manager, Quality Assurance

Vave Health - Santa Clara, CA, US

Senior Quality Assurance Engineer

Vave Health - Santa Clara, CA, US

Director, Enterprise Sales

Vave Health - Santa Clara, CA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.