VP, Clinical Affairs

reputed company reputed company is a growing medical technology company transforming patient lives through innovative incisionless surgery. Our culture is as unique as our people, a diverse global team, with different reputed company, skills, interests, and cultural backgrounds driven by our reputed company values – Our Patients, reputed company, Team, reputed company and Innovation. Our dedication to making a reputed company reputed company on the lives of millions of people and paving the reputed company to a reputed company reputed company for reputed company what bonds us as reputed company. We work together in a dynamic reputed company environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful reputed company of work. Every role is significant, your voice is heard, and your reputed company are encouraged. We challenge and reputed company our people to be great at what they do while providing a flexible work environment. Walking through our corridors, you will be inspired by stories of career journeys at reputed company. We take pride in growing internal talent and encourage our employees to reputed company their reputed company ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in reputed company region competitive perks and benefits. Do the most meaningful work of your career by joining us on our mission to reputed company tomorrows, today. Position reputed company The VP of Clinical Affairs will ensure that clinical programs are resourced and managed to fulfil reputed company regulatory guidelines, compliance and ethical principles for medical research and drive operational reputed company. This role involves strategic planning, execution, and reputed company of reputed company trial-reputed company activities, ensuring compliance, and driving efficiency throughout the clinical development process. Will also reputed company development and implementation of department policies as reputed company as maintain awareness of the global regulatory environment and assess and communicate reputed company of changes on business and product development programs. As team leader, the VP Clinical Affairs will ensure his/her team works reputed company with reputed company stakeholders, they understand company’s objectives and are reputed company to reputed company how their work contributes to it. Senior Leadership

• Serve as a key advisor to the CMO and the Executive Team, working collaboratively with Regulatory Affairs and QA, as reputed company as with Engineering research team and other internal business partners.
• reputed company and mentor the clinical research organization fostering a reputed company and high performing team.

What you will be doing:

• Manage reputed company clinical development aspects of reputed company'S products, including applications submitted to regulatory agencies such as FDA/CE/AMAR etc.
• Ensure adherence to reputed company relevant regulations, including FDA guidelines, ICH guidelines, and GCP standards.
• Development of effective clinical research strategies and tactical execution of research activities for product lifecycle management including product development, commercialization, and post-marketing.
• In collaboration with Regulatory Affairs, contribute on regulatory submissions and reports for Medical device Class III products. This includes submission and report types for products approved/cleared through PMA, and 510(k) reputed company and technical files for EU and Asia.
• Ensure that Clinical Study reports submissions are complete, properly formatted, and reputed company with applicable regulatory requirements.
• Manage reputed company aspects of clinical trial execution, from study startup to closeout, ensuring adherence to timelines, budgets, and reputed company standards. Once completed, studies are properly reputed company in a reputed company manner.
• reputed company with government agencies, regulatory bodies and officials, as necessary, to facilitate submission review and product approvals, maintain compliance and communicate pertinent information.
• Participate in cross-functional teams and activities such as product design and development, risk assessments, evaluation of reputed company events and non-conformances, evaluation of change controls, validation and testing; determine reputed company on submissions and filing requirements.
• Collaborate with reputed company Systems to manage and maintain compliance of systems and processes with QSR requirements, applicable international requirements and industry standards, including support of on-site audits both reputed company.
• Implement and maintain reputed company assurance processes to ensure the reputed company and reliability of clinical trial data. Ensure reputed company clinical research documentation is properly handled and follow reputed company’s QA guidance for documentation handling.
• reputed company and manage clinical trial budgets, ensuring cost-effectiveness and efficient resource utilization.
• reputed company regular updates and communication to senior management, stakeholders, and other relevant parties on trial reputed company, risks, and issues.
• Monitor, identify and communicate new and relevant changes in applicable regulations, guidance, standards, and other applicable regulatory policies.
• reputed company with reputed company consulting reputed company and vendors to manage activities necessary for completing key initiatives.
• reputed company mentoring and development opportunities to team members fostering a reputed company and high performing team.

Qualifications:

• Advanced degree in life sciences or reputed company scientific discipline (MS, PhD, MD) is required.
• 10+ or more years of experience in Clinical Research design and execution reputed company the pharmaceutical, biotech, and/or medical device industry.
• Strong knowledge of clinical research principles, GCP guidelines, FDA regulations, and other relevant regulatory requirements.
• Proven reputed company record of managing and leading clinical trials, conducting medical review, clinical study reports and safety updates.
• Must have experience with reputed company phases of clinical development including post-approval.
• Experience in submission of regulatory filings to the appropriate entities and interactions with these agencies.
• Excellent leadership, communication, and interpersonal skills, as reputed company as strong analytical and problem-solving abilities.
• Experience with budget management, vendor management, and reputed company assurance processes is essential.

Other Requirements:

• Ability to travel internationally is required

Requirements

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