As a Design Quality Engineer, you will be responsible for quality system aspects of new products. In addition, you will also lead ECOs associate to design changes of released products and manufacturing process changes. Scope Responsibilities:
QA focal point for new products and engineering projects in R D. Responsible for product risk assessments and design reviews, work closely with R D to develop appropriate qualifications for both new design and changes to already released designs. Responsible for DHF and DMR documentation. ECOs management including assignments tracking and reporting quality metrics for the management. Support US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages. Participates in internal and external audits i.e. internal audits, FDA inspections, notified body audits according to ISO13485, EUMDR, MDSAP.

Maintains up to date knowledge, ensures adherence and compliance with local regulatory requirements and associated documents
Ensures all start up information & requirements are kept up to date in a central repository for project teams
Registration of Company studies, conducted in Israel, in the Israeli Ministry of health (MoH) mytrial website
Works in close collaboration with the study Clinical Project Manager (CPM) and the assigned Regulatory representative for the study, provides status updates on an ongoing basis, escalates when required
May assist with the translation and co-ordination of translations for documents required for submission
Contributes to the study start-up activities including local adaptation of study master ICF(s)
May be delegated to act as the primary contact with investigative sites during site start-up activities
May support in the collection and distribution of documents from / to sites
Ensures all essential documents are reviewed in accordance to local regulations and SOP
Prepares Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
Responsible to prepare and submit EC and MoH (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Tracks metrics and study start-up timelines to identify trends and opportunities for improvement
Interacts with multiple cross-functional teams to facilitate and assist in obtaining and compiling response letters to the ECs or MoH
Tracks and prepares for submission, throughout study duration, on an ongoing basis per local regulatory requirements
Participates and provides status updates during weekly study team meetings
Collaborate with TMF on regulatory submitted docs
Identifies, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment estimation or strategy and study non-compliance
Keeps up to date with evolving regulation in collaboration with Regulatory and Legal
May actively support MoH inspection and pre-inspection activities
May support audit preparation & Corrective Action and Preventative Action (CAPA) preparation for local related issues.

you will serve a valued part in the regulatory team preparing submissions files and keeping life cycle management. You will make the Ministry of Health submissions (variations and renewals) and have inner organizational interfaces. You will be preparing packaging materials and will work with several computerized systems.

The company is looking for a Regulatory Affairs and Compliance Engineer to join our growing team.
Responsibilities:
* Identify and assess product risks and hazards.
* Support product quality control measures by conducting operations and processes involved in final product safety.
* Review emerging risks and risk control implementation and effectiveness.
* Provide a regulatory framework for risk reduction verification and validation.
* Assess hazards, risks, and controls in a manner consistent with established procedures and practices.
* Support risk management throughout the organization that emerges from non-conformities (MRB), design and process changes, and post-production and device experience (PMS).
* Collaborate with other teams including R&D, V&V, QA, and Customer Support to assess risk control implementation and effectiveness.
* Report to Regulatory Affairs Manager.

Prepare and control submissions of technical documentation (e.g. clinical study reports, labelling materials) submitted to regulatory authorities, and ensure they are up-to date
Maintain contact with regulatory authorities, distributors and local partners to ensure the company remains compliant with regulatory and quality requirements
Advise the company, and in particular the R D, Product, Operations and Quality teams, on applicable standards and regulations
Conduct research and analysis of regulatory requirements and policies for new markets the company is looking to enter with existing and future products and monitor regulatory developments and changes to ensure continued conformity with regulatory requirements.
Maintain existing regulatory registration files and ensure applicable regulatory requirements

* Working closely with the regulatory and clinical team to implement regulatory strategies and secure excellence, and compliance to the new MDR 2017/745
* Full knowledge of Alma systems and accessories and how they meet their intended use and indications including available clinical evidence to support.
* Extended Knowledge of clinical standards and regulations.
* Writing and/or updating CEP&CERs, OMs, PMCF plans and PMCF reports, PSUR to be shared with NB (including biostatistics expertise for sample size determination and trends analysis and rationales)
* Supporting risk analysis process for existing and new projects
* Working with Contract Research Organizations to assist with the regulatory and clinical writing – including control of their work and deliverable a setting appropriate expectation to maintain compliance to required standards and regulation.
* Gathering and analyzing regulatory, marketing, R&D, service, sales information to properly update the PMCF database
* Scientific writing
* Review product promotional materials, labeling for compliance with applicable regulations and policies
* Perform gap analysis on updated or new applicable clinical laws, guidelines, standards, and guidance
* Participate in product development meetings, as required, to ensure the product follows all internal and external worldwide clinical regulatory requirements.
* Handling clinical& regulatory aspects of adverse events and vigilance
* Participating on deficiency letters and report to NB