Director of Clinical AffairsLeads the Clinical Affairs function for in vitro diagnostic and point-of-care products, with responsibility for clinical strategy, study planning, execution, and clinical evidence generation. Oversees clinical performance studies and post-market activities supporting regulatory submissions, product development, and lifecycle management while ensuring compliance with regulatory requirements, timelines, budgets, and quality standards.Note this is a hybrid opportunity requiring 3-5 days/week onsite at a Greater Boston location.ResponsibilitiesDevelop and lead clinical affairs strategy aligned with product development, regulatory, and post-market evidence needsLead clinical study design, planning, execution, monitoring, and reporting including timelines, budgets, and risksDevelop, review, and approve clinical study documentation including protocols, reports, and regulatory support materialsOversee clinical site selection, start-up, conduct, and close-out ensuring data quality and complianceEnsure studies comply with applicable regulations, standards, and internal proceduresManage Clinical Affairs personnel, external partners, and vendors while supporting team developmentPartner with Regulatory Affairs to support submissions and clinical evidence requirementsCollaborate cross-functionally with R&D, Quality, Manufacturing, Medical/Scientific, and MarketingImprove clinical processes, metrics, and governance practices to support efficiency and data integrityRepresent Clinical Affairs in leadership discussions and provide updates, risk assessments, and recommendationsExperience & Requirements10-15+ years of experience in the IVD (in vitro diagnostics) sectorExperience with point-of-care and critical care technologiesExperience managing or performing clinical trials and evaluationsExperience preparing scientific publications and presenting at conferences or seminarsExperience developing and managing Key Opinion Leader relationshipsFamiliarity with international clinical standards and regulations including ISO 14155, ISO 20916, or ICH E6Compensation & Benefits$225,000-$235,000 salary$20% performance based annual bonus401K company matchFlexible medical, dental, and vision coverageTuition assistancePTO, paid holidays
...Licensed Social Worker (Non-Mental Health) to perform remote quality reviews for the U.S. Department of Veterans Affairs. This position... ...of related experience. Responsibilities include analyzing medical records and providing structured assessments of care quality, emphasizing...
We want you to help us shape the future of shopping experiences and deliver on our purpose of connecting people with the products and experiences that enrich their lives. Joining Advantage Solutions means joining a network of 65,000 teammates serving 4,000+ brands and ...
...Certified Occupational Therapy Assistant (COTA) - Full-Time Autumn Lake at Summit Park | Catonsville, MD $36-$40/hour | Full-Time | Benefits Ultimate Therapy is hiring a Certified Occupational Therapy Assistant (COTA) to become part of the rehabilitation...
...both single and multi-semester co-ops and internships. College students must apply to the requisition pertaining to their major and semester... ...for employment visa status now or in the future (e.g., F-1 CPT/OPT, H-1B, TN, etc.) will not be considered. More about the...
...Web Designer You are a visually driven Web Designer who enjoys transforming product requirements, user needs, and brand direction into polished, engaging digital experiences. You have a strong eye for visual hierarchy, typography, composition, spacing, and detail,...