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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

What you will be doing:
* Provide regulatory support to the Development and Post marketing activities related to our products.
* Preparation and maintenance of regulatory submissions and registrations of our products in relevant markets.
* Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
* Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
* Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination.
* Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review)
* Actively participate in the evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations
* Provide support for all external/internal audits at HQ and globally, as needed
* Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues.
* Work closely with various other teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed.
* Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure ongoing regulatory compliance
* Attend other regulatory related needs, as required
* Working according to our Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.

The Regulatory Affairs Specialist provides regulatory guidance for business unit product lines. The Regulatory Affairs Specialist works directly with cross functional teams to support global product market clearances .

Your role:
Act as the Regulatory Affairs representative for CT/AMI products, supporting regulatory activities such as labeling, marketing, technical documentation, global registrations, and regulatory design change assessments within the product Development Life Cycle.
Provide regulatory guidance to cross-functional teams throughout all design control phases for new products and major/minor changes.
Coordinate and prepare document packages to support global submissions and regulatory activities.
Support regulatory audits and compliance activities.
Serve as the local regulatory liaison between markets and the BIU site.
Maintain Product Shipment Authorization for CT/AMI product lines, ensuring compliance with localization and licensing requirements

we are looking for a Regulatory Affairs Specialist
What you will be doing:

Provide regulatory support to the Development and Post marketing activities related to INSIGHTEC products.
Preparation and maintenance of regulatory submissions and registrations of INSIGHTEC products in relevant markets.
Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination.
Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review)
Actively participate in the evaluation of changes to the INSIGHTECs QMS documents and device design/process for impact on pending or existing registrations
Provide support for all external/internal audits at HQ and globally, as needed
Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues.
Work closely with various other INSIGHTEC teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed.
Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure ongoing regulatory compliance
Attend other regulatory related needs, as required
Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.