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Head of Clinical & Regulatory Affairs #1930 - Tampa Florida
Company: FloodGate Medical
Location: Tampa, Florida
Posted On: 05/01/2025
Head of Clinical & Regulatory AffairsCompany: Versono MedicalVersano Medical is a MedTech company focused on improving outcomes for patients with vascular occlusions. Based in Galway, Ireland, they develop innovative technologies for endovascular surgery, particularly for Critical Limb Ischemia (CLI). Their goal is to enable physicians to effectively treat vascular occlusions, reducing amputations and mortality rates. Versano's technology platform aims to cross occlusions, prepare vessels, and support intravascular therapies.Why You Should Join UsThis is a Head of Clinical & Regulatory Affairs role in the Eastern US area. You will be responsible for providing clinical and regulatory guidance to support Versono's product portfolio as it develops. The ideal candidate will possess exceptional interpersonal and written communication skills, a detailed working knowledge of regulatory and clinical requirements, and hands-on experience in monitoring and managing clinical trials. Experience in peripheral vascular device technologies and collaborating with key opinion leaders to introduce new technologies in clinical settings is highly desirable.What You'll DoAs a Head of Clinical & Regulatory Affairs, you will: - Assist clinicians by providing procedural and technical support during clinical study activities.
- Be responsible for ongoing Clinical Affairs, providing education support to investigators, research staff, and institution personnel at clinical trial sites.
- Lead activities for site and practitioner identification, selection, and qualification.
- Facilitate contracts, agreements, and budgets.
- Support site initiation and ongoing training and education of coordinators, physicians, and support staff as necessary.
- Manage the enrollment of appropriate candidates to meet study objectives and achieve company goals for clinical studies.
- Interact with Versono's cross-functional team as needed to keep information updated on site dynamics, enrollment, and study needs.
- Develop and design clinical studies.
- Work with physicians and CROs.
- Formulate strategies to ensure that Versono's products comply with relevant regulations and standards throughout their lifecycle.
- Ensure that the company adheres to all relevant regulations, standards, and guidelines, advising the company on potential impacts.
- Prepare and submit regulatory documents to appropriate agencies (e.g., FDA, EMA) for Versono's product approval and registration.
- Act as the primary contact with regulatory authorities, managing communications and submissions.
- Be responsible for Regulatory Compliance (PRRC) as per article 15 of MDR 2017/745.
- Lead or participate in cross-functional project teams, ensuring regulatory requirements are met on time and within budget.
- Provide strategic input into business planning and decision-making from a regulatory perspective.
- Support the company's efforts to enter new markets by ensuring compliance with local regulations.What You'll Need
- Advanced degree (Master's, PhD, or MBA) in Clinical Research, Regulatory Affairs, or related discipline preferred.
- Minimum 8-10 years of experience in an active CA/RA role, including designing, conducting, and managing clinical trials for medical devices.
- Ability to align clinical and regulatory activities with the company's business objectives.
- Proven track record in securing regulatory approval for clinical studies and post-market surveillance activities.
- Experience with Clinical Evaluation Reports (CERs) and related documentation under EU MDR regulations.
- Comprehensive knowledge of EU Medical Device Regulation (MDR), ISO 13485, and other applicable international standards (e.g., FDA CFR 21 Part 820, MDSAP).
- Demonstrated experience in regulatory submissions, such as CE marking, FDA 510(k), or PMA processes.
- Expertise in handling regulatory inspections and audits by notified bodies or competent authorities.
- Minimum 5 years of leadership experience, managing cross-functional teams in clinical and regulatory functions.
- Demonstrated ability to influence and collaborate with senior stakeholders and external partners.
- Strong project management capabilities.
- Able to travel as required.
- Able to work independently and as part of the broader team.
- Knowledge of ICH and GCP guidelines.
- Bachelor's degree in a relevant field such as Life Sciences, Biomedical Engineering, Pharmacy, or similar or equivalent relevant years of industry experience.Perks of the JobCompensation:Base: TBD, DOEBonus: TBD, DOEOther Benefits:
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