Meditrial · 1 day ago
Clinical & Regulatory Affairs, Director
New York, NY
Full-time
Onsite
Director/Executive
10+ years expMeditrial is a key player in the medical device and pharma sector, seeking a Director of Clinical & Regulatory Affairs. This role involves providing strategic direction to the Regulatory & Clinical Affairs teams, overseeing the development and execution of global regulatory and clinical strategies.
Clinical TrialsMedicalPharmaceutical
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
Qualification
Required
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
Company
Meditrial
Meditrial drives clinical research acceleration with leading edge technology to reach milestones with simplicity, speed and efficiency.
51-200 employees
Funding
Current Stage
Growth StageRecent News
globalventuring.com
2026-01-16
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