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.
Develop an efficient and effective Usability program consistent with international regulatory requirements and FDA guidance.
Lead the construction and execution of both formative and summative usability activities for SaMD applications
Generate Regulatory Submission content for Usability Engineering, including Plans, Reports, Use Error Analysis and Traceability
Radformation is transforming the way cancer clinics deliver care. Their innovative software automates and standardizes radiation oncology workflows. They are a fully remote, mission-driven team united by a shared goal to reduce cancer’s global impact and help save lives.
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.
Monitors all safety aspects of clinical research trials.
Collects, assesses and processes Adverse Events (SAE) for safety reporting.
Prepares narratives of adverse events for adjudication by the CEC.
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. At Cordis, teammates bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives.
Participate in Ro’s cross-functional advertising review process, evaluating creative assets for FDA advertising and promotion compliance.
Serve as an internal subject matter expert on FDA advertising and promotion requirements.
Stay abreast of changes in FDA regulations and industry trends in health product advertising.
Ro is a direct-to-patient healthcare company with a mission of helping patients achieve their health goals by delivering the easiest, most effective care possible. Ro is the only company to offer nationwide telehealth, labs, and pharmacy services and is consistently recognized as a top workplace.
Review course scripts and assessments for regulatory accuracy.
Identify outdated or unclear content based on current laws.
Recommend improvements to enhance learner comprehension.
EasyLlama is transforming the HR compliance industry by reinventing outdated training solutions for the mobile-first generation, aiming to reduce employee risk and foster inclusive environments. With over 5,000 clients and a 96% rating on G2, they emphasize collaboration, innovation, and a culture of getting things done.
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.
Liaise with regulatory authorities on technical/regulatory questions.
Provide technical expertise to the global Medical Devices network.
Manage the team of IVDR product assessors and IVDR IHC.
SGS stands as the world's foremost testing, inspection, and certification company, recognized globally for sustainability, quality, and integrity. With 99,600 employees across 2,600 offices and laboratories, we foster a dynamic, international culture committed to high professional standards and long-term employee development.
Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
Provide internal teams and Clients with expertise and guidance on national requirements.
Ergomed Group is a rapidly expanding global full-service mid-sized CRO specializing in Oncology and Rare Disease. The company includes the more specialised brands- PrimeVigilance, Adamas Consulting and Ergomed CRO and values employee experience, well-being and mental health.
Supports the development and execution of global regulatory strategy.
Maintains relationships with relevant regulatory agencies.
Identifies risks and interpret and communicate relevant issues to project team members and senior management.
Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. It is committed to continuous innovation in cell therapy, with a diverse and inclusive work environment.