Regulatory Affairs (RA) & Clinical Specialist
Healthy.io is one of the first companies to successfully turn a smartphone into a clinical-grade medical device enabling faster treatment and improved care for patients around the world. Our products combine computer vision and machine learning technology and best-in-class UX design to create new clinical pathways through smartphone powered urinalysis and digitized wound management.
As we rapidly grow, we are looking for an RA & Clinical Specialist with regulatory and clinical research basic knowledge to join our RA/QA team.
As RA & Clinical Specialist you will write submissions, fill out all forms, work and Interact with product managers, production and development teams, as well as assist with the overall maintenance of clinical trials and regulatory documents.
The RA & Clinical Specialist will be responsible for assisting in planning, coordinating, and conducting clinical research projects. Ensuring compliance with research protocols, adherence to clinical objectives, and supporting the smooth operation of clinical studies. In addition, the RA & Clinical Specialist will be required to provide administrative assistance to the clinical project team and take part in various tasks associated with running a large-scale clinical trial. Supporting RA projects , including the transition of the company to a new European regulation system: MDR, IVDR.
Role & Responsibilities
· Supporting the activities and processes required to assure that products manufactured and distributed are in compliance with all
applicable regulatory requirements.
· Assisting in the planning and preparation of submissions to obtain regulatory approvals for new and modified medical devices.
· Preparation for tests, supporting engineering changes in the product/quality system.
· Prep submission including 510(K), technical files, AMAR submissions
· Notifications of changes, Letter to File
· Learning new standards and training relevant staff
· Provide administrative and technical support for designated clinical research personnel
· Assist in the preparation of study documentation, forms, and the development of administrative and filing systems
· Assist with the collection, review and tracking of regulatory documents and EDC data.
· Familiarity with standards and regulation
· Knowledge of clinical trial processes and ICH/GCP guidelines
· Minimum 2 years experience in RA for medical device companies
· experience as an RA for software companies-advantage
· Academic degree in Software, Precision Sciences - Advantage
· Attention to detail and ability to manage multiple tasks
· High verbal and written skills in English