About the position
Healthy.io is the first company to successfully turn the smartphone camera into a clinical-grade medical device, enabling faster treatment and improved care for patients worldwide. Our products combine computer vision and machine learning technology with best-in-class UX design to create new clinical pathways through smartphone-powered urinalysis, digitized wound management, and beyond. Headquartered in Tel Aviv with 70 employees across the US and UK as the main markets the company operates in.
We’re looking for a seasoned and driven Director of Regulatory Affairs & Quality Assurance to lead Healthy.io’s global RA/QA efforts. In this role, you’ll play a critical role in driving the planning and execution of regulatory submissions and the maintenance of robust quality systems. You will work closely with cross-functional teams across Product, R&D, Operations, Clinical, and Commercial to ensure our innovative digital health products comply with international regulations and standards, enabling safe, effective, and timely access to care. The Director of RA/QA will report directly to the company’s Chief Product Officer.
This encompasses ensuring compliance with all relevant standards and laws for every product manufactured by Healthy.io as well as managing the creation and upkeep of the Design History Files (DHFs), Device Master Records (DMRs), Technical Files (TFs) and submissions, registrations and communications with regulatory bodies for every device in every relevant market.
Requirements
- 8+ years of experience in regulatory affairs and quality assurance roles in the medical device companies, encompassing software-based medical device companies.
- Significant hands-on experience with FDA and CE, including deep understanding of ISO 13485, FDA QSR regulations and related standards, the MDR, IVDR European regulations and other regulatory frameworks.
- Demonstrated success in preparing and submitting regulatory files (e.g., 510(k)s, Technical Files, PSURs, etc.).
- Experience leading audits and inspections by regulatory bodies. Specifically, certified to lead 13485 supplier audits.
- Strong written and verbal communication skills in English.
- Ability to work independently and collaboratively in a fast-paced, cross-functional environment.
- Strategic thinker with a hands-on attitude and the ability to operate both tactically and at a leadership level.
- Academic degree in exact sciences such as chemistry or biology - Advantage
Role & Responsibilities
- Define, implement, and lead Healthy.io’s global regulatory strategy, including FDA, CE, MHRA and other relevant jurisdictions.
- Oversee the development, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with ISO 13485, 21 CFR Part 820, and other applicable standards and laws.
- Lead all QA activities which include supplier evaluations and audits, CAPAs, non-conforming products and review of manufacturing records and release company’s batches to the market according to the approved product specifications.
- Act as the lead contact with regulatory authorities and notified bodies. Manage submissions, audits, inspections, and registrations in all applicable markets.
- Own and manage regulatory submissions for product changes, ensure implementation of design control and SDLC, and maintain the Design History Files (DHFs), Device Master Records (DMRs), Technical Files (TFs) of all products.
- Ensure company-wide compliance with post-market surveillance requirements including complaint handling, adverse event reporting, field actions, and periodic safety reports.
- Collaborate with cross-functional stakeholders including R&D, Product, Clinical, and Operations to ensure regulatory and quality considerations are integrated early into the product lifecycle.
- Act as a subject matter expert internally, providing guidance and training to teams on regulatory and quality matters.
- The Director of RA/QA serves as the Person Responsible for Regulatory Compliance (PRRC) and the Quality Management Representative.
or send your CV to [email protected]