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Senior Quality Systems and Compliance Manager

HealthMode was created to improve clinical trials with AI-enabled patient measures. We develop products that collect patient data from real-world settings and transform them into quantifiable clinical measures providing evidence for clinical trials and patient care. We follow a 3-step product validation path - product feasibility study, data collection and model development, clinical validation. On this path, we develop industry and clinical research partnerships that support the development and adoption of the new measures. We integrate regulatory discussions throughout our process to speed up innovation adoption within the pharmaceutical industry.

HealthMode is seeking a motivated candidate who is passionate about supporting the growth of our innovative company committed to improving clinical trials and our understanding of how to measure health. As Senior Quality Systems and Compliance Manager you lead our efforts to build a Quality Management System (QMS) with an eye towards ISO 13485 certification in 2021 as well as meeting evolving regulatory expectations in clinical trial technologies.

In this role, you will help drive the growth and help shape the future of an emerging function that will have a significant impact on our business and digital health measurement at large. You will be responsible for identifying, developing, and driving the HealthMode Quality Systems/Quality Management Systems program as we develop our portfolio of digital measurements with an eye towards SaMD (software as a medical device) clearance in the US and beyond.

You should have a deep Quality Systems/QMS skill set including QMS development and QMS management for medical devices, a working knowledge of clinical trial processes and technologies. Must be open to occasional travel across the United States, with potential for occasional European travel. This is a remote role based in the U.S.

Responsibilities

  • Collaborate with internal teams and colleagues to determine and implement optimized compliance and quality strategy to best support our product, portfolio and business needs
  • Participate in discussions with external partners to evaluate and/or inform optimized compliance and quality systems implementation strategy for collaborative projects
  • Collaborate with internal colleagues on development of procedures and necessary compliance issues

Qualifications and Experience

  • 4+ years of life sciences experience in R&D, compliance, regulatory, or related functions, with at least 2 + years in managing Quality Systems.
  • 2 + years experience in QMS/QS related audits and compliance including both internal and external audits.
  • 1+ years experience in hosting client audits (in person and or remote).
  • Applied ISO 13485 experience- this role will be critical to paving the way to certification.
  • Working knowledge of relevant US FDA and EMA QMS/QS regulations and guidances.
  • Experience with interactions with regulatory authorities
  • Interest and passion for digital products in clinical research and care
  • Comfort in communicating and presenting to customers and senior leadership
  • Strategic thinker with the ability to communicate and execute a strategy consistent with partner needs
  • Strong verbal and written communication skills

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HealthMode, Inc is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, political affiliation or belief.

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