Leads global regulatory strategy and compliance for Merge Healthcare’s medical imaging portfolio.
Oversees global product registrations, device licensing, and market authorization activities.
Provides leadership and expert guidance on emerging regulations and standards.
Merative provides data, analytics, and software for health and social care. It is a medium-to-large company with a remote-first culture and values focus, speed, trust, and inspire.
Leads writing and preparing clinical and regulatory documents for drug and device development.
Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
Develops knowledge of US and international regulations and participates in process improvements.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.
Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out.
Lead sponsor-side CRO and vendor management across the full study lifecycle.
Translate study requirements into operational plans and drive study-level strategic decision-making.
Oura empowers people to own their inner potential with award-winning products that provide insights into readiness, activity, and sleep quality. As a quickly growing company, we focus on helping people live healthier and happier lives, ensuring our team members have what they need to do their best work.
Provide strategic leadership and oversight for all clinical data management activities across the development program.
Partner with cross-functional leaders to ensure data integrity and support timely, high-quality decision making.
Oversee vendor management, data governance, and delivery of inspection-ready clinical data.
Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases like MASH. They are a team of problem solvers with a collaborative culture, dedicated to bringing out the best in each other.
Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
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.
Provides study-level oversight and leadership for global clinical trials from inception through closure, managing vendors, recruitment, and cross-functional teams.
Develops and manages study materials including protocols, regulatory submissions, and budgets while ensuring compliance with quality standards and inspection readiness.
Contributes to system management like EDC, IRT, and eTMF, and supports process improvement initiatives or serves as a mentor.
AbbVie discovers and delivers innovative medicines and solutions to address serious health issues in immunology, oncology, neuroscience, and aesthetics. As a global biopharmaceutical company with a robust pipeline, they emphasize integrity and innovation, serving patients worldwide with a dedicated team.
Set strategic direction and lead large clinical trials and data collection efforts.
Manage clinical research operations, including site selection, budgets, and regulatory compliance.
Author publications and represent the company at major annual conferences.
Hanger is the world's premier provider of orthotic and prosthetic services and products, offering advanced solutions and clinical programs. With 160 years of history, the company operates nationwide clinics and employs thousands, focusing on empowering human potential through superior patient care.
Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production with a focus on quality and compliance.
Provide oversight of CROs, vendors, and internal teams, recruiting and leading CDM staff to meet clinical trial timelines and budgets.
Partner cross-functionally on data management issues, identify risks, and propose solutions to ensure inspection-ready, high-quality data.
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and traded on Nasdaq (DFTX), the company is advancing a new generation of therapeutics with a focus on turning evidence into impact.
Provide clinical development leadership at the study level for clinical stage assets in early and/or late development.
Serve as medical monitor for one or more studies and perform ongoing clinical trial data review.
Contribute to clinical development strategy and author clinical and regulatory documents.
Deciphera is a biopharmaceutical company focused on developing new medicines to improve the lives of people with cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Manage and lead a team of Clinical Specialists and 1099 contractors for clinical support and case coverage.
Develop and deliver clinical education to sales, clinical specialists, and surgeons to achieve exceptional patient outcomes.
Collaborate cross-functionally with Quality, Regulatory, Marketing, and R&D to support new product development and clinical education.
We are a medical device company focused on improving kidney stone treatment. We are a small to medium-sized team with a culture that values diversity, collaboration, and high achievement.
Lead pharmacovigilance strategies and safety signal detection for Apogee's pipeline.
Collaborate with cross-functional teams to ensure high-quality safety data for regulatory submissions.
Provide medical oversight of safety data and contribute to benefit-risk assessments.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics for inflammatory and immune-mediated diseases. Founded in 2022 and publicly traded, the company operates with a fast-paced culture grounded in C.O.R.E. values: Caring, Original, Resilient, and Egoless.
Partner with subject matter experts to assess training needs and design effective learning solutions across translational sciences, clinical operations, and regulatory compliance.
Coordinate new hire onboarding and maintain training documentation, records, and reporting in accordance with regulatory expectations.
Manage learning platforms, deliver instructor-led and e-learning programs, and serve as primary intake point for training requests.
Precision for Medicine is a global precision medicine clinical research services organization that integrates clinical operations, laboratory expertise, and advanced data sciences to improve clinical research and development. The company focuses on trials from early development through approval, with embedded experience in oncology and rare disease, and operates as part of Precision Medicine Group.
Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products.
Lead and oversee interactions with FDA, EMA, and other global regulatory agencies.
Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages.
Enveda reinvents drug discovery by harnessing nature's intelligence, identifying new medicines four times faster than the industry standard. The company achieved unicorn status after a $150M Series D in 2025, has an award-winning culture recognized by Newsweek and Forbes, and values creativity, collaboration, and deep respect for each team member.
Lead integrated drug development strategies across preclinical, clinical, regulatory, and commercial dimensions for pharmaceutical and biotech programs.
Provide expert guidance on clinical development plans, target product profiles, study designs, and regulatory submission strategies.
Engage with global regulatory authorities and support portfolio management, licensing, and business development decisions.
Jobgether uses AI-powered matching to connect candidates with hiring companies. They process applications efficiently and share shortlists with employers, supporting a global, inclusive work environment focused on innovation.
Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.
Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.
Manage a team of 15-17 Study Management Associates (SMAs) to deliver best-in-class study execution.
Drive performance management, mentoring, and professional development for direct reports.
Support resource management, adherence to regulations, and continuous process improvements.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company operates across several therapeutic areas including immunology, oncology, and neuroscience, with a significant global presence and a culture focused on innovation and impact.
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.