Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support CE Mark submissions.
Interact with cross-functional teams to define strategies for clinical documentation and regulatory submissions.
Conduct literature searches, critically appraise scientific data, and write clinical summaries for products and surgical procedures.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies like the da Vinci surgical system and Ion to transform surgery. The company is a team of engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human, with challenging but deeply meaningful work.
Review CMC sections of regulatory submissions for drug-device combination products, ensuring accuracy and alignment with global requirements.
Contribute to global regulatory CMC strategies and provide guidance to cross-functional stakeholders.
Collaborate with device development, quality, clinical, human factors, and other teams to support product compliance and change controls.
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.
Lead regulatory and quality strategy for product development and lifecycle management.
Coordinate regulatory submissions and maintain documentation for SaMD products.
Support design change assessments and ensure compliance with FDA, EU MDR, and ISO 13485.
Oura empowers people to own their inner potential through its award-winning Oura Ring and connected app, providing daily insights on readiness, activity, and sleep. As a quickly growing health technology company, Oura fosters a culture of empowerment and well-being, ensuring team members have the resources to do their best work.
Oversee CRO and vendor activities while directly contributing to study start-up and conduct including site initiation and monitoring visits.
Verify accuracy and completeness of clinical data, source documentation, and regulatory files ensuring compliance with GCP, GDPR, and regulations.
Identify and resolve discrepancies in study documentation and maintain Trial Master File for audit readiness.
Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care through biomimetic TAVR valves. The company has a growing and inclusive team with offices in the US, Switzerland, and Australia.
Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA), post-market surveillance, and quality system audits.
Collaborate cross-functionally with R&D, Quality Assurance, and Sales to ensure compliance with U.S. FDA and international regulations (ISO 13485, MDSAP, EU MDR).
Perform regulatory documentation and submissions for new products and changes, and handle customer complaints, field actions, and risk assessments.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and fosters a dynamic, flexible environment focused on innovation and collaboration.
Manage the intake, review, analysis, and reporting of Individual Case Safety Reports (ICSRs) and support Clinical Events Committees and Data Monitoring Committees.
Co-author and maintain study-specific safety documents and prepare aggregate safety reports for regulatory submission.
Collaborate with sponsors, study teams, and cross-functional partners to ensure data quality and compliance with GCP and GVP standards.
This partner company delivers high-quality safety services across clinical research and medical device programs. They foster a collaborative, detail-oriented environment with a focus on compliance and patient outcomes.
Deliver clinical education and training to physicians and hospital staff during surgical study cases in the US.
Plan activities to support recruitment at sites and ensure compliance with clinical protocols and regulations.
Support multiple studies with different protocols and travel up to 70% within the Central US region.
Kuros Biosciences is a Swiss-headquartered biotech company focused on advancing bone healing with high-quality scientific evidence. With operations in the Netherlands and the USA, we continue to grow our global team and have a commercial and research footprint spanning over 20 markets.
Own cybersecurity compliance for connected hardware products, including threat modeling and security validation.
Translate security findings into technical documentation and risk assessments for regulatory frameworks like RED and CRA.
Collaborate with engineering teams to embed security early in the development lifecycle.
Nabu Casa develops the Home Assistant open-source smart home platform, focused on privacy and local control. The company is a distributed team with a culture of autonomy, ownership, and sustainability.
Own the quality system for international markets, including product release, complaints, and supplier oversight.
Build and run EU Quality Management System processes for compliance across the product lifecycle.
Work cross-functionally with Regulatory, Supply Chain, and external partners to ensure product quality and regulatory compliance.
Grüns provides comprehensive, real nutrition through gummies made from 60 whole-food ingredients. The company is a small, fast-growing remote team that values ownership, high standards, and urgent impact, with a high-trust culture and biannual in-person offsites.
Manage EU export documentation, customs compliance, and broker coordination.
Handle non-standard shipments, HS code classification, and preferential trade procedures.
Collaborate with cross-functional teams to improve customs processes through automation.
Xometry operates a digital marketplace connecting product designers and buyers with global manufacturing capacity. As a NASDAQ-listed company, it serves Fortune 1000 clients and fosters a remote, collaborative culture.
Lead the application of the Clinical Quality Management Regime across Delivery Partners, ensuring compliance with contractual quality standards.
Use quality intelligence and performance data to assess effectiveness of controls and identify emerging risks.
Provide hands-on clinical quality expertise to diagnose performance issues and support corrective actions.
Ingeus is a leading human services provider that helps people, businesses, and communities thrive through employment, skills, and health & wellbeing services. It is a trusted partner to government and industry, committed to creating positive social impact, and fosters an inclusive culture treating everyone with dignity.
Manage remote client engagement and application processing for PCA/PVoC services.
Ensure completeness and compliance of documentation for Certificate of Conformity issuance.
Act as central coordination point between clients, on-site sales affiliates, inspection, and laboratory teams.
SGS is the world’s leading inspection, verification, testing and certification company. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
Provides regulatory CMC support for drug-device combination products.
Reviews submission documentation and contributes to global regulatory strategies.
Collaborates with cross-functional teams including device development, quality, and clinical.
Vertex Pharmaceuticals is a global biotechnology company dedicated to developing transformative medicines for serious diseases. With thousands of employees, it fosters a collaborative and innovative culture focused on patient impact.
Reviews, analyzes, and challenges audit outcomes and clinical decision-making.
Identifies emerging quality themes and contributes to continuous improvement.
Ingeus is a leading human services provider helping people, business and communities thrive through employment, skills and health & wellbeing services. They are a trusted partner to government and industry with a culture built on treating everyone with dignity.
Lead end-to-end GCP auditing processes, including scheduling, conducting, reporting, and follow-up for sites, vendors, and internal processes globally
Apply deep knowledge of FDA, EU, and ICH regulations to independently resolve compliance issues and represent GDQA on cross-functional teams
Develop risk-based audit strategies, mentor new staff, and support regulatory inspections with 6+ years of experience including 4+ years direct GCP auditing
Regeneron is a leading biotechnology company that invents life-changing medicines for people with serious diseases. Founded and led by physician-scientists for over 30 years, we have developed nine FDA-approved treatments and numerous candidates, fostering a culture of innovation recognized as a Great Place to Work.
Own cybersecurity compliance for connected hardware products, including RED, EN 18031, and CRA.
Perform threat modeling, security validation, and manage vulnerability risks across firmware, cloud, and devices.
Collaborate with engineering teams to integrate security early and translate technical findings into compliance evidence.
Nabu Casa builds cloud services and hardware for the open-source Home Assistant smart home platform. It is a profitable, fully remote company with no external investors, funded by users, and supports several open-source projects.
Critically evaluate scientific literature and produce accurate regulatory documents.
Manage writing assignments across multiple projects and ensure timely delivery.
Work directly with clients and multidisciplinary teams on regulatory submissions.
A partner company in the pharmaceutical, biotechnology, and medical device sectors is hiring a Senior Medical Writer. The company offers a fully remote environment and opportunities to work on a broad portfolio of clinical and regulatory documents.
Lead portions of regulatory assessments, external audits, and accreditation processes for Commercial, Medicare, Medicaid, and Marketplace departments.
Act as primary point of contact for internal and external partners on regulatory activity, quality efforts, SOP development, and client delegation agreements.
Maintain regulatory gap status reporting, track work streams, and lead change management related to regulatory requirements.
Prime Therapeutics is a pharmacy benefit manager (PBM) with a purpose beyond profits, reimagining pharmacy solutions to connect care for those they serve. The company is a large, purpose-driven organization focused on simplifying healthcare and fostering a collaborative culture.
Manage reprocessing and infection control activities for the endoscopic product portfolio, serving as the primary company resource and subject matter expert.
Work cross-functionally with customers, third-party companies, and internal stakeholders to ensure reprocessing recommendations satisfy US market needs and comply with industry guidelines.
Develop validation programs, technical manuals, and educational tools while representing the company on national committees and keeping leadership informed of trends.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and is guided by a Group Purpose of giving our world more smiles, offering a dynamic and flexible work environment.