לוח משרות דרושים רישום / רגולציה רפואית

a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care - from the hospital to the home. Job Description: Managing the post market RA team which handles the following activities: Support design and post market compliance of products from a regulatory perspective Handling Vigilance, MDR and authorities inquiries of complaints Support the investigation process from a regulatory perspective Responsible for managing product field action Responsible on regulatory assessment related QMS process Responsible of companys PSUR Direct manager: VP of R&A

At our company, we empower businesses to thrive in todays fast-paced world. As a Platform licensing Program Manager, you will oversee large, cross-functional licensing programs that have a direct impact on our companys long-term business success. Your focus will be on program ownership, strategic alignment, and process governance across multiple teams and domains. 
This role requires exceptional leadership to drive cross-functional collaboration, influence decision-making at all levels, and foster a culture of accountability and innovation. Strong stakeholder management skills are essential for aligning diverse teams, balancing competing priorities, and ensuring smooth execution of large-scale licensing initiatives. Additionally, analytical skills are critical for identifying trends, assessing risks, and leveraging data-driven insights to inform strategic decision-making, anticipate challenges, and proactively solve problems before they impact program success.
What youll do:
This role provides a unique opportunity to be a part of our licensing strategic programs, collaborate with cross-company stakeholders, enhance transparency, and optimize delivery outcomes while ensuring regulatory compliance and adherence to timelines. As such, this role will focus on:
Licensing Program Ownership: Lead end-to-end planning and execution of strategic licensing programs that span multiple teams and domains.
Stakeholder Coordination: Ensure cross-functional teams (Legal, Compliance, GTM, Product, R&D, Finance, etc.) are aligned and working towards shared objectives. 
Risk & Dependency Management:  Identify and mitigate cross-company alongside external regulatory risks, constraints, and dependencies to prevent execution bottlenecks and ensure smooth progress.
Process & Governance: Maintain governance structures, reporting mechanisms, and tracking frameworks to ensure visibility across all stakeholders levels including executive management.
Strategic Impact: Ensure that licensing programs adhere to regulatory expectations while maintaining a high level of execution excellence. Drive measurable outcomes that significantly contribute to business growth and product scalability.

you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
The Regulatory Affairs Post-Market Specialist leads and executes key post-market activities to ensure compliance with the Israeli Ministry of Health (AMAR) and requirements. This includes managing adverse event (vigilance) reporting, coordinating Field Safety Corrective Actions (FSCAs), and serving as a regulatory contact for post-market issues in Israel. The role involves close collaboration with cross-functional and global teams to maintain the highest standards of quality and patient safety.

Responsibilities may include the following and other duties may be assigned:
Lead the execution and follow-up of Field Safety Corrective Actions (FSCAs) including coordination with internal teams, customers, and submission to the Ministry of Health (MOH)
Manage the adverse event (vigilance) reporting process to the Israeli MOH, ensuring timely and accurate submissions in accordance with local regulatory timelines and guidelines
Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities
Serve as a regulatory contact for the Israeli MOH on all post-market issues, including adverse events, recalls, field actions, and periodic updates
Stay up to date with changes in AMAR regulations, MOH guidelines, and industry standards, and communicate potential impacts to management and relevant teams
Participate in the local recall committee or crisis response team in the event of product safety issues requiring urgent action
Provide training to local teams on vigilance reporting, complaint handling, and FSCA procedures to ensure consistent and compliant practices

We are looking for a Medical writer and Regulatory Affairs associate.
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.
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.

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.

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!
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.