Support regulatory operations for SaMD products across development, submission, launch, and post-market phases
Coordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondence
Maintain regulatory documentation, including: submission trackers, product registrations/listings, regulatory commitments, approvals and clearance records, and change assessment logs
Oura's mission is to empower every person to own their inner potential. Their award-winning products help their global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. As a quickly growing company focused on helping people live healthier and happier lives, they ensure that their team members have what they need to do their best work — both in and out of the office.
Preparation and submission of regulatory dossiers.
Advise on strategies and registration requirements for product development and marketed products.
Lead regulatory assessment and actions for changes to product and QMS processes.
Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. They have more than 10,000 colleagues and provide products and services in around 90 countries, promising to be forever caring.
Provide oversight for medical device software products through all phases of the development process.
Guide the software development team to define critical safety and performance requirements.
Support the timely handling of complaint investigations, change impact assessments, and CAPAs.
Oura's mission is to empower every person to own their inner potential with award-winning products that help their global community gain a deeper knowledge of their readiness, activity, and sleep quality. They have offices in San Francisco, San Diego and Los Angeles for those who prefer hybrid or office settings, and they're committed to ensuring that their team members have what they need to do their best work.
Act as the Person Responsible for Regulatory Compliance (PRRC) under EU Medical Device Regulation (MDR).
Partner closely with Product, Engineering, Machine Learning and Data, Customer Care and Legal teams.
Help build and strengthen Docplanner's regulatory framework, directly supporting EU MDR compliance and global expansion.
Docplanner Group's mission is to help people live longer, healthier lives. As the world’s largest healthcare platform, they connect 24 million patients with 280k doctors across 13 countries. Docplanner's marketplaces, SaaS and AI tools simplify daily tasks and help doctors, clinics and hospitals work more efficiently.
Prepare, compile, and submit regulatory documents to IRBs/ECs
Support migration from Complion to Florence eRegulatory
Maintain CVs, licenses, and GCP documentation
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Support regulatory strategy and submission timelines for US market
Own quality oversight of supplier relationships for US market
Lead CAPA investigations and effectiveness verification
Optain is a healthcare company using software and hardware to rethink care. They aim to improve the way we detect and manage eye and systemic conditions and have a close-knit and highly talented team.
Establishes and maintains a document management system for regulatory electronic files.
Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.