Provides leadership, direction and support for the implementation and sustainable initiatives to document clinical evidence for select Sonablate Corp. products. Serves as the subject matter expert who manages clinical performance, scientific validity, and analytical performance activities for the organization. Responsible for providing leadership and expertise for the development of pre-market and post-market clinical evidence strategies for medical devices across product platforms. Ensures effective execution of compliance activities in accordance with international standards, regulatory requirements, customer requirements, and Sonablate Corp.’s standard operating procedures.
The Clinical Affairs Manager will play a direct role in Sonablate Corp.’s overall compliance with product requirements in domestic and international markets.
· Leads domestic & international clinical evidence activities prescribed by applicable regulatory agencies
· Coordinates with the cross-functional teams and key stake holders to determine scope and design of the applicable clinical evidence gathering strategies, e.g., clinical studies, registries, patient-level surveys
· Investigate regulatory and clinical submission requirements, help prepare regulatory and clinical submissions (PMA, 510k). Be the liaison for the company to the FDA.
· Understands or willing to become the subject matter expert for using international trial data for future FDA submissions
· Collaborate with the Research and Developmentteam to develop new indications for existing devices, and new indications fornew devices, helping to see these through from inception to approval, inclusiveof developing trial protocols and establishing trial sites
· Participates in design validation activities(i.e. usability studies, limited market releases, etc.) from a clinical perspective, encouraging and assisting with the validation activities in the field of new designs.
· Develops, implements, and maintains protocols needed to conduct scientific validations and to generate relevant clinical evidence for regulatory submissions
· Responsible for implementing data collection systems and ensure data collection is maintained by the sites
· Develops and maintain clinical documents, including clinical plans, protocols, forms, and reports.
· Prepares written final reports containing interpretations and conclusions that are supported by results from data analysis
· Leads the development of pre-market and post-market clinical evidence strategies with cross-functional teams.
· Assists with collecting and analyzing real-world data for the purposes of continually evaluating the device risk and harm analyses.
· Establishes and maintains ongoing collaborative relationships with leadership, marketing, sales and customer support teams to provide objective, evidence-based scientific and clinical information.
· Engages with marketing and other applicable internal departments to ensure that all studies, presentations, and messaging are aligned with the strategic goals of the business.
· Ability to plan and manage complex and successful projects
· Education and/or experience equivalent to an advanced degree in the medical, nursing, biological, physical or engineering disciplines (e.g., Masters, PhD, RN, PharmD)
· Minimum of six years of clinical research, clinical study, clinical data synthesis/analysis, and/or clinical writing experience in the medical device or pharmaceutical field
· Experience working within the framework of ISO13485 international standards, FDA 21CFR820, and quality management systems
· Experience developing and executing pre- and post-market clinical evidence strategies, including PMCF in support of EUMDD/MDR certification
· Experience with ICH, Good Clinical Practices, FDA’s Quality System Regulation, ISO 13485, MDD/MDR, JPAL, CMDR, PMA, 510k,healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices.
· Ability to read, analyze, and interpret clinical literature, regulations, guidance documents, clinical and medical terminology, technical product information and complex documents.
Excellent scientific analytical skills
· Knowledge and experience in basic statistical methods
· Strong team-orientation with demonstrated ability to both lead and follow cross-functional team.