Oversee sterilization processes within medical devices and provide technical support across all certification schemes as a fully remote role.
Lead a team of MDR Product Assessors-Sterilization, manage resource planning, and drive team performance against global targets.
Develop and maintain sterilization QMS documentation aligned with best practices and applicable regulatory requirements.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability, quality, and integrity. With 99,600 employees operating a network of 2,600 offices and laboratories, we offer a dynamic, international work environment with a focus on professional development and sustainability.
Provides administrative and scientific support for APHL's Infectious Disease efforts, including vaccine preventable disease testing capability and capacity.
Facilitates activities for national conferences, training courses, and meetings, including logistics and promotional materials.
Develops and disseminates information through updates on program website, newsletters, and other communication avenues.
APHL strengthens laboratory systems serving public health in the U.S. and globally. Its member laboratories monitor and detect infectious diseases, environmental contaminants, and other health threats, with a collaborative and mission-driven culture.
Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA) and facility registration.
Coordinate complaint investigations, risk assessments, and field action notifications while ensuring compliance with ISO 13485 and MDR.
Collaborate with cross-functional teams to prepare documentation, support QMS audits, and maintain regulatory records.
Fujifilm Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, enterprise imaging, and endoscopic/surgical imaging. With over 70,000 employees globally, the company operates in a dynamic, flexible environment that fuels creativity and collaboration.
Provide quality oversight of sterile drug product and finished drug product manufacturing, labeling, packaging, and distribution operations.
Review and approve batch production records, process validation documents, and quality system records such as deviations and change controls.
Support regulatory agency inspections and author NDA CMC sections to ensure compliance with GMP and GDP standards.
Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs, such as post-bariatric hypoglycemia, Wolfram syndrome, and ALS. The company has an experienced team driven by core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of caring.
Develop global clinical strategies to support clinical evidence requirements for product submissions.
Ensure adequate monitoring is conducted on all clinical trials and work directly with regulatory bodies for approvals.
Select, interface with, and assure training of investigators, physicians, and clinical staff.
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance patients' lives, and supplies high-end niche batteries for specialized markets. We are guided by six Values: Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity, fostering a culture of passionate excellence within our team of over 10,000 employees.
Provide clinical case coverage and train surgical teams on device use.
Manage inventory, perform quality control, and ensure compliance with policies.
Collaborate with commercial team to support positive clinical outcomes.
Calyxo is a medical device company focused on improving kidney stone treatment. It is a startup with a dynamic, diverse team led by experienced executives.
Perform scheduled maintenance, troubleshooting, and repairs on da Vinci Surgical Systems within assigned territory.
Coordinate system installations, hardware delivery, and ensure compliance with O.R. protocol and HIPAA standards.
Complete administrative duties, maintain inventory, and support sales teams and customer training as needed.
Intuitive is a pioneer and market leader in robotic-assisted surgery, expanding the potential of physicians to heal without constraints. For over 25 years, they have built a diverse and inclusive team of passionate people committed to making a difference in healthcare.
Install and maintain Growth Direct systems to meet customer expectations.
Complete preventative maintenance and emergency repairs on time.
Develop technical and communication skills with guidance from senior FSEs.
Rapid Micro Biosystems develops innovative products for fast, accurate detection of microbial contamination in pharmaceutical manufacturing. The company is a growing global leader in microbiology automation with headquarters in Massachusetts and field offices worldwide.
Conduct remote audits of medical device quality management systems against ISO 13485 and EU MDR.
Review objective evidence, identify findings, and deliver structured audit reports.
Apply sound regulatory judgement and support continuous improvement of audit processes.
The partner company specializes in assessing innovative health technologies and ensuring regulatory compliance for medical devices. It operates with a quality-focused culture, valuing autonomy and regulatory expertise.
Drive sales revenue and market share inside the regional territory, pursuing new business and implementing strategic plans to achieve a 10% annual increase.
Nurture current customer accounts through routine calls, product demonstrations, and in-services, developing relationships with physicians, nurses, and hospital administration.
Coordinate clinical demonstrations with the Clinical Sales Specialist, become an expert in reprocessing techniques, and support VIP customers as directed.
FUJIFILM Healthcare Americas Corporation innovates for a healthier world with cutting-edge healthcare solutions including diagnostic imaging, endoscopic and surgical imaging, and in-vitro diagnostics. The company is part of Fujifilm, a global leader with over 70,000 employees, driven by the purpose of giving our world more smiles.
Responsible for ensuring total customer satisfaction within the Werfen installed base, performing installations, validations, and training on analyzers.
Provides ongoing clinical support, customer education, and consulting on regulatory requirements and compliance.
Identifies opportunities to grow revenue and may assist Sales with lead generation through pre- and post-sales support.
Werfen is a worldwide leader in specialized diagnostics in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. They are a family-owned, innovative company with over 7,000 employees operating in 30 countries directly and 100+ territories through distributors.
Conduct coder QA, provide educational feedback, and develop performance improvement plans.
Prepare and present coding curricula and regulatory updates to coders and providers.
Utilize revenue cycle knowledge to analyze coding data, support audits, and maintain shared resources.
US Anesthesia Partners is a leading provider of anesthesia services and revenue cycle management. The company operates across the US and emphasizes a collaborative culture focused on compliance and quality.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.
Perform scheduled maintenance, troubleshooting, and repairs on Intuitive products within an assigned territory.
Coordinate system installations and ensure compliance with O.R. protocol and HIPAA standards.
Complete administrative duties including inventory, field activity reports, and expense reports in prescribed timeframes.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies like the da Vinci surgical system. The company employs engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human.
Perform surveillance inspections of factories to ensure products remain compliant with certification conditions.
Support department objectives and company goals while maintaining a professional and positive attitude.
Communicate with customers professionally and adhere to service standards.
Eurofins Scientific is an international life sciences company providing analytical testing services to ensure safety and authenticity of products. With 58,000 staff across 900 laboratories in 54 countries, it is a global leader in testing and laboratory services.
Provide procedural support to new robotic system sites to promote safety and effective progression.
Offer expert clinical product and technical assistance to physicians and clinical staff on Intuitive equipment during procedures.
Collaborate with US Clinical Applications Engineering and development teams to support new users and share best practices.
Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to advancing minimally invasive care through intelligent technology. The company has been built by a diverse team of passionate individuals committed to making a difference, fostering an inclusive culture focused on growth and mutual respect.
Execute regulatory strategies for obtaining registration approval of Intuitive's medical device portfolio in APAC indirect markets.
Coordinate with Distributor RAs and internal stakeholders to compile regulatory documentation and ensure compliance with medical device regulations.
Manage regulatory submission tracking in systems like Veeva and perform periodic surveillance activities using TrackWise.
Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to advancing minimally invasive care. The company has built an inclusive and diverse team of great people for over 25 years, grounded in integrity and a strong capacity to learn.
Provide regulatory advice and ensure compliance with U.S. regulations and ICH GCP guidelines for clinical research sites.
Coordinate IRB submissions, maintain regulatory documentation, and support site start-up and close-out activities.
Collaborate with cross-functional teams and monitor regulatory changes to advise stakeholders.
Care Access is working to make the future of health better for all by bringing world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Assess hardware, software, and network issues on medical imaging systems via remote troubleshooting and diagnostics.
Provide advanced support and guidance to Customer Support Engineers and collaborate on complex technical issues.
Maintain expert knowledge of medical imaging products and ensure compliance with regulatory and quality requirements.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics, along with Non-Destructive Testing solutions. With over 70,000 employees globally, we are guided by our Group Purpose of 'giving our world more smiles' and foster a dynamic, flexible environment.
Lead medical work across sponsor-direct trials, including encoding new trials, iterating screening rules with engineering, and supervising a small medical contractor team.
Perform hands-on EMR review and clinical reasoning while setting strategic medical direction and contributing to customer and business conversations.
Partner with engineering to refine automated EMR screening, defining clinical logic for patient exclusion and human review, and contribute to product and trial design.
HealthMatch is on a mission to advance medicine by connecting patients with clinical trials. With over 2 million patients in our database and a growing trial portfolio, we are closing the gap in trial recruitment through technology and patient engagement.