לוח משרות דרושים רישום / רגולציה רפואית

Required Hardware regulatory compliance engineer
As a member of the Regulatory Affairs Department the Systems Regulatory Compliance Engineer will be part of the Hardware products Global Market Access team, responsible for escorting hardware design, certifying products towards global standards, verifying health and environmental regulations compliance, and testing for electromagnetic & radio compatibility.
Essential Duties and Responsibilities:
To monitor, interact, report, and support R&D, Engineering, and regional teams that inquire about aspects of compliance matters, enforcement actions, remedial activities, and regulatory compliance affairs.
Lead product evaluations and tests by operating external laboratories, advisors, and subcontractors to meet relevant Safety, EMC, and Environmental certifications.
Perform product safety reviews, and preliminary safety testing, facilitate agency inspections, and maintain product regulatory compliance files.
Evaluate regulatory trends and revisions.
Preparation of Technical files including the creation of a Critical Component List
Supervisory Responsibilities:
External contractors and test laboratories, cross-organization projects management
Physical/Environmental Requirements:
Work in an office environment with periodic visits to factory locations.
Domestic travelling up to 10%.

We are currently seeking a Product Compliance officer.
What You'll Do
Responsebilities: Conduct thorough reviews and assessments of our gaming and betting products and generate detailed gap analysis of regulation and standards required for new market entry.
Collaborate with cross-functional teams including Legal, Project, Product, Security, to implement compliance measures throughout the product lifecycle.
Provide guidance and support to product development teams on compliance-related matters, including product design, feature implementation, and testing.
Monitor and analyse changes in regulations and standards, and communicate updates and implications to relevant stakeholders, and track their implementation.
Track internal audits and assessments to identify areas of non-compliance and implement corrective actions.
Coordinate with external regulatory bodies, 3rd-party laboratories and auditors as necessary to facilitate compliance certifications and approvals.
Act as a subject matter expert on product compliance issues.

We are looking for a Medical writer and Regulatory Affairs associate.
Primary function of the position:
Clinical scientific knowledge and writing skills to effectively and clearly communicate medical science information in writing. Generally, focus on either scientific medical writing, which includes clinical studies, and regulatory documents, scientific articles or marketing medical writing. Experience in regulatory aspects (RA), help to lead regulatory strategy and provide ongoing regulatory input.
Roles and Responsibilities:
Work with clinical teams and clients to understand the nature of the scientific work that they will be covering.
Assess data or products using medical expertise, and quickly develop expertise in new areas as needed for their writing.
Help to write studies for submissions to the FDA. The writing is also used in publications or medical journals, or for internal company use.
Comprehensive writing of clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
Prepare abstracts, scientific exhibits, posters and verbal presentations.
Help with develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
Conduct comprehensive literature searches to enhance background understanding, and evaluate and analyze the information which will be written about.
Provide responses to regulatory agencies regarding product information or issues.
Maintain current knowledge of relevant regulations, including proposed and final rules. Help in manage activities such as audits, regulatory agency inspections etc.
Participate in the development or implementation of clinical trial protocols. Preparation and submission of regulatory agency applications, reports, or correspondence.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

committed to maintaining the highest standards of compliance and ethical practices within its operations. As part of our growing compliance team, we are seeking a highly organised and experienced Product Compliance Officer. This role presents a unique opportunity to support different business units within the Group, including both B2C and B2B segments.
What You'll Do
Conduct thorough reviews and assessments of our gaming and betting products and generate detailed gap analysis of regulation and standards required for new market entry.

Collaborate with cross-functional teams including Legal, Project, Product, Security, to implement compliance measures throughout the product lifecycle.
Provide guidance and support to product development teams on compliance-related matters, including product design, feature implementation, and testing.
Monitor and analyse changes in regulations and standards, and communicate updates and implications to relevant stakeholders, and track their implementation.
Track internal audits and assessments to identify areas of non-compliance and implement corrective actions.
Coordinate with external regulatory bodies, 3rd-party laboratories and auditors as necessary to facilitate compliance certifications and approvals.
Act as a subject matter expert on product compliance issues.

In this role you are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, clients policies and procedures, quality standards and adverse event reporting requirements internally and externally. You would be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

With the support of exceptional people and an energized purpose, youll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.

In this role you are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, clients policies and procedures, quality standards and adverse event reporting requirements internally and externally. You would be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

A Global medical high-tech Company located in Shoham, is seeking a Quality Assurance and Regulatory Affairs Specialist with experience managing the development of medical devices through the approval process. The ideal candidate will have a strong regulatory and quality knowledge throughout product lifecycle with aspects of effective management and strategy.
Responsibilities & Scope of work:
Supports and maintains EU- MDR submission related activities (QMS, Technical Files, GSPR and PMS) and liaises with regulatory authorities
* Participation in internal and external audits e.g., FDA, Notified Body etc. for regulatory affairs matters - Oversight and performance of routine QA activities such as: ECO, MRB, NC, Monitoring of Calibrations, Training and Qualification, Customer Complaints, CAPA, Document and Record Control, Approval of qualification and validation activities etc.
* Control of processes in compliance with the applicable regulations and company procedure requirements - Participate in Management Reviews and analyze quality data
* Work closely with R&D through product development process and design activities.
* Support risk management activities including hazard analysis and FMEA. - Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.
* Support and improve company Quality Systems by creating a quality culture and provide ongoing education on compliance activities.
* Contribute towards accomplishment of departmental and corporate goals and objectives
* All other duties as requested by his/her manager.