לוח משרות דרושים מדעי החיים, טבע וחקלאות בצפון

Our company is a fast-growing, global leader in energy-based solutions for Aesthetics and Eye-Care.
We are based in Yokneam (with offices also in Tel-Aviv) with a strong business performance worldwide.
Our company is looking for a Clinical Director for the Aesthetics Business, which includes a broad portfolio of leading solutions in the market as well as an exciting innovation pipeline.
The Clinical Director will be responsible for pre- and post-market activities for the assigned product portfolio and will lead a team of Clinical Managers.
The Director will own all clinical aspects including: pre-clinical, clinical input to regulatory submissions and registrations, market conditioning for new solutions, post-market evidence generation and KOL development.
The individual will serve as a major pillar in building relationships with global KOLs and demonstrating the value of benefits of the solutions.
Key responsibilities:
- Own the Clinical Strategy for assigned portfolio and be a key contributor to overall Business strategy.
- Lead all R&D clinical activities for assigned portfolio including: bench-top, pre-clinical ex-vivo and in-vivo, validation, usability and more.
- Lead post-market clinical activities for evidence generation and training: clinical trials and different clinical activities (sponsored, IIT, grants) according to GCP(ISO-14155/MDR/CFR) and following company SOPs, protocol development, training development and more.
- Lead the clinical input and support for key regulatory submissions and processes: regulatory submission clinical input, clinical validations, CER, CDP, CEP and more.
- Support marketing/commercial activities from the scientific/medical point of view: review and input to marketing collateral, develop white papers, active participation in scientific meetings and more.
- Lead a team of clinical managers and oversee the relevant budget.
- Form and cultivate strong collaborative relationships with cross-functional partners in R&D, product, marketing and regional teams.

Required Quality Sys Eng - P4
Yokneam, Israel
ID: 577277
Main Duties:
Member of integrated product team (IPT)- responsible for supporting activities required to ensure quality of the design though compliance with design controls.
Lead proactive design assurance activities facilitating the development and release of high-quality products.
Review and approve product design document- in accordance with design controls standards and companys policies. This includes but is not limited to design verification and design validation activities.
Parenting with R&D- ensures design control processes are maintained and continuously improved to ensure on-going compliance to all applicable regulation and standards.
Assure proper documentation and execution of design planning, inputs and outputs, design review, V&V, risk analysis and design change per company and regulatory requirements.
Support audits and compliance assessments of DHF and other program files to ensure quality and regulatory requirements are met.
Partnering with R&D, RA, Clinic affairs and BU, ensure that pre-release elements of risk management activities are properly conducted and included within the applicable risk management file.