לוח משרות דרושים רפואה ופארמה

As a dental labeler you will be responsible for labeling dental records, identifying various dental conditions and findings. You will be able to work remotely from your home and in flexible hours as convenient for you, except for some training that will be face to face in Align offices.

As a regulatory affairs expert, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities

In this role, you will
Be a focal point for the RA team members to solve professional issues
Train the junior team members in their onboarding process and on specific skills and knowledge development.
Develop of regulatory strategies for product development and approval, as well as product lifecycle maintenance. Develop global strategy for product launch.
Prepare document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
Implement MDR requirements related efforts in the organization
Assess product changes and their global regulatory impact.
Support license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post approval changes
Coordinate project submission timelines in multiple regions
Escalate issues that affect registration, regulatory compliance and continued lifecycle management of the product

In this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities
In this role, you will
Actively contribute in the development of regulatory strategies for product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities with different partners and their global strategy for product launch.
Perform coordination and preparation of document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
Coordinate and implement MDR requirements related efforts in the organization
Assess product changes and their global regulatory impact.
Lead or compile all materials required in submissions, license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changes
Coordinate project submission timelines in multiple regions

The Technical PM will take part in leading activities related to the Disposable Sleeve to increase production yield reduce MRB and initiate cost reduction activities, lead NPI activities to achieve robust manufacturing of Aligns products.
You will work closely with other disciplines in the organization to coordinate various activities such as purchasing, R&D, Quality, Planning, Production both in Israel and abroad.
Key Responsibilities
In this role, you will
Manage Projects of different scales, specifically Production automation projects
Establishing and maintaining projects Gantt, tracking projects progress, recognizing risks and applying mitigations
Leading Engineering Changes Orders as the prime interface to introduce necessary engineering/R&D changes while understanding the implications in Logistic, Testing and Production
Compose DVP /IOQ / PQP protocols for validation of changes at production line qualification