Source Job

• 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.

• 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.

• Assist in preparing regulatory submission documents in compliance with global regulatory requirements.
• Manage the preparation and submission of preclearance and promotional material submissions to the U.S. FDA.
• Format complex Word documents to generate compliant regulatory reports including complicated tables and graphs.

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

• 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.

• 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.

• Providing strategy based on regulatory requirements.
• Completing regulatory and PV deliverables based on established plan.
• Acting as Local Contact Person for Pharmacovigilance for designated country.

PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners and value employee experience, well-being and mental health.

• Lead and manage technical functions for all medical schemes, globally.
• Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements.
• Drive continuous improvement of technical workflows and quality management processes.

SGS is the world's leading testing, inspection, and certification company, recognized as the global benchmark for sustainability, quality, and integrity. With 99,600 employees across 2,600 offices and laboratories, we enable a better, safer, and more interconnected world.

• 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.