לוח משרות דרושים רישום / רגולציה רפואית משרה מלאה

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.

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 products.
Preparation and maintenance of regulatory submissions and registrations of 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 Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve. We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us! We are hiring PV Associate. Monitoring and reporting adverse events and safety information, ensuring compliance with regulatory safety guidelines and conducting activities to monitor and enhance the safety profile of Medison’s products

Responsibilities:

* Receiving, translating, processing and documenting any reports, from overseas or locally, regarding adverse events and safety information of Medison’s products in compliance with regulatory requirements
* Submitting timely and accurately safety reports to the Ministry of Health in compliance with local regulatory requirements
* Actively following-up on adverse events reported by physicians and patients
* Collecting and reviewing safety and efficacy measures taken by health authorities in recognized countries. This includes monitoring publications, regulatory updates, and safety communications from agencies such as the FDA, EMA, and other global health organizations to ensure compliance and up-to-date safety practices for Medison’s products
* Reviewing relevant data from the scientific literature related to drug safety. This includes conducting literature searches to identify new safety information, adverse events, and emerging safety issues
* Promoting awareness among healthcare professionals and medical teams regarding the importance of reporting adverse events to ensure public safety
* Conducting periodic internal and external reconciliations
* Assisting in preparation for PV audits and inspections
* Conducting PV trainings to Medison’s employees and external suppliers
* Additional tasks as defined by the manager

Manages and train Regulatory Affairs representatives and associated processes for preparation of product submissions, including 510(K), CE Technical Files (MDD and MDR), China, Canada, Japan, South Korea, and Australia and other International Countries.
Interact with Internal and External teams on regulatory related projects to meet regulatory compliance topics and regulatory tasks.
Lead the development and implementation of regulatory strategy for assigned projects of the relevant BU
Collaborate with Sr. Director Regulatory regarding EU, China, Japan, South Korea, Taiwan and other global territories regulatory teams for to implementation of develop global regulatory strategies for projects and submissions.
Approving labeling (including advertising and promotional materials) in the context of submissions or registrations and serving as the regulatory expert of the projects.
Provide regulatory advice and guidance to Regulatory Affairs representatives, engineering, and project teams to ensure submissions meet regulatory requirements and maintain up-to-date knowledge of regulatory requirements.
Manage, mentoring and train International Regulatory Associates/Leads for product submissions.
Will support and partner with Internal teams and functions in phases of design, development, production, and distribution of medical devices.
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.

we offer hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve. We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us! As a QP Pharmacist, you will be Responsible for ensuring compliance with all ongoing control processes designed to guarantee that products are not released to the market until it is determined that their quality matches the approved specifications in the registration file. In addition, responsible for quality processes in the regulatory affairs department that will be adapted to international standards, local regulations, where applicable, and the organizational quality level established for medical products. This is a temporary position for 8 months.
Responsibilities:

* Qualified Person Responsible Pharmacist of the importer.
* Ensuring Compliance with Israeli Regulations: The QP is responsible for ensuring that all pharmaceutical products meet the standards set forth by Israel's Ministry of Health (MoH) and other relevant regulatory authorities. Review the product batch release documentation and authorizing or rejecting the batch release to the market. Certification of Compliance: to certify that each batch of the product has been produced and tested according to relevant specifications and regulations before it reaches the market.
* Accompanying regulatory audits and being responsible for regulatory knowledge, document control, writing procedures, maintaining and updating relevant professional literature, and assisting in planning training activities in the field.
* Liaison with the MOH and working according to the MOH guidelines, including immediate reporting of any complaint or recall if necessary.
* Responsible for batch releases of registered and non-registered products.
* Review PQRs and full batch records provided by the partners.
* Execution of additional supervisors instructions and tasks accordingly.