Clinical & Regulatory Affairs, Director

Responsibilities: Develop and maintain a strong organization of clinical and regulatory experts who demonstrate respect for teamwork and a commitment to successful results Provide overall leadership and direction including clear communication of objectives, the development of key strategies and tactics, and oversight of performance on a continuative basis to the regulatory and clinical study teams Provide guidance, training and interpretation of regulatory policies and guidelines on a cross-functional level (i.e. CRAs, Regulatory specialist, QA team, SW verification and validation team). Collaborate with stakeholders for the development of regulatory and clinical strategies to support regulatory approvals Oversee regulatory submissions and publications to ensure clinical results are interpreted and documented clearly and concisely Collaborate with stakeholders during FDA interactions, including pre-submissions, FDA applications, and submissions for market approvals. Liaise with the FDA and global regulatory authorities, fostering a collaborative relationship Provide insight and guidance for audits by FDA and European Notified Bodies Interact with Investors as well as supporting VC fundraising due-diligence activity Establish relationships with key opinion leaders in the industry, ultimately in order to engage in new business opportunities Provide input to stakeholders to assure worldwide regulatory requirements and standards are incorporated in the product development process Provide leadership; Monitor applicable global regulatory and clinical requirements Qualifications & Personal Skills

Education: Bachelor's degree in Life science, Master in a scientific/health-related field is a plus A minimum of 10-15 years plus experience in clinical research, preferably for medical devices 10+ years of Regulatory Affairs experience in the medical device industry 10+ years of experience in people management and leadership experience within the clinical/regulatory functions Knowledge and experience with quality systems regulations and guidelines, ISO, MDD, MDR, FDA and other regulatory requirements. Knowledge and experience of GCP/CFR/ICH guidelines, ISO9001 and ISO14155 ISO 13485 Must understand, follow and comply with regulatory requirements as applicable to various processes. Solid understanding of FDA Quality System Regulations Ability to be self-motivated, work independently and balance multiple priorities in a fast-paced regulated environment. Strong organization and planning skills with an attention to detail and ability to handle multiple tasks with accuracy. Ability to effectively present information to top management and/or the scientific community. Established relationships with KOLs in the fluid monitoring space. Ability to management medical advisory boards and clinical studies.