Source Job

• 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.

• 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.

• Plays an essential role supporting Manager, Medical Content Development on content development-related engagements.
• Writes and creates medical and scientific content related to Medical Affairs, Medical Information and Medical Communications.
• Drives the client document development process from gathering materials and developing scientifically rigorous content to facilitating document review.

EVERSANA provides next-generation commercialization services to the life sciences industry, helping to bring innovative therapies to market and support patients. With over 6,000 employees worldwide, they foster an inclusive culture that values diversity and collaboration.

• 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.

• Review, annotate, and amend early- to late-stage publication manuscript drafts.
• Work on rapid turnaround deliverables following guidance set by Sci Comms Solutions Lead and Product Manager.
• Liaise with Authors to take manuscripts to submission.

Sorcero's medical AI platform transforms life sciences decision-making, accelerating patient access to life-saving treatments. Founded in 2018, it is a Certified B Corp headquartered in Washington, DC, recognized with awards for its innovation in medical AI.

• Manages the Interventional GI & Accessory product offering, working cross-departmentally with various stakeholders internally and externally.
• Build and maintain strong relationships with Key Opinion Leaders (KOLs) in the marketplace.
• Develop and drive 3-to-5-year strategic plans for Interventional GI & Accessory platform(s).

FUJIFILM Healthcare Americas Corporation innovates for a healthier world with cutting-edge healthcare solutions that span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics. Fujifilm is globally headquartered in Tokyo with over 70,000 employees.

• Serve as the primary legal advisor on medical device regulatory requirements.
• Partner cross-functionally with Product, Science, Regulatory Affairs, and Engineering teams.
• Establish scalable product development governance frameworks.

Oura's mission is to empower every person to own their inner potential through award-winning products like the Oura Ring and its connected app. They've helped millions understand and improve their health with insights and practical steps, ensuring team members have what they need to do their best work.

• 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.

• 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.

• Organize editorial project teams to deliver research and competitive intelligence initiatives.
• Complete data and fact checking based on annotated source materials.
• Review scientific content for grammar, punctuation, style, consistency, and overall flow.

Lockwood collaborates with pharmaceutical, biotech, and medical device clients to create effective, science-based medical communications strategies. They have a flexible structure providing better work-life balance, attracting top talent and improving client responsiveness.

• 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.