Regulatory Affairs Manager jobs in Israel

Description About Pi-Cardia Pi-Cardia is a growth-stage medical device company focused on developing innovative solutions for structural heart disease. Founded in Israel, with expanding operations in the United States, Pi-Cardia combines clinical excellence, technological innovation, and entrepreneurial agility. Our team works closely with leading physicians and global partners to bring meaningful, life-improving therapies to patients worldwide. We are building a high-performance organization that balances rapid growth with operational discipline, regulatory excellence, and a strong people-first culture. Position Overview We are looking for an experienced Regulatory Affairs Specialist to join our growing Regulatory Affairs team. In this role, you will help drive global regulatory strategies and ensure compliance throughout the product lifecycle of our innovative cardiovascular medical devices. You will work closely with cross-functional teams to support product development, regulatory submissions, design changes, and market access, playing a key role in bringing life-changing technologies to patients around the world. Responsibilities • Prepare, review, and maintain regulatory submissions and registrations for medical devices in global markets, with a primary focus on the U.S. (FDA) and European Union (EU MDR). • Support regulatory strategy development for new product introductions, design changes, and lifecycle management activities. • Manage Engineering Change Orders (ECOs) from a regulatory perspective, including assessment of regulatory impact, documentation updates, and submission requirements. • Compile, maintain, and update technical documentation, regulatory dossiers, and supporting documentation in accordance with regulatory requirements. • Ensure compliance with EU MDR, FDA regulations, and applicable international standards throughout the product lifecycle. • Monitor changes in regulatory requirements and assess their impact on existing and future products. • Collaborate cross-functionally with R&D, Quality Assurance, Clinical, Manufacturing, and Marketing teams to ensure regulatory compliance. • Support regulatory assessments, risk management activities, labeling reviews, and design change evaluations. • Participate in audits and inspections and provide regulatory support for quality management system activities. • Maintain regulatory records and ensure timely renewals, registrations, and submissions. Requirements • Bachelor's degree in Life Sciences, Biomedical Engineering, Engineering, Pharmacy, or a related field. • 4–8 years of Regulatory Affairs experience within the medical device industry. • Proven experience with medical device regulatory submissions and registrations in the United States and Europe. • Strong knowledge of FDA medical device regulations and European Medical Device Regulation (EU MDR 2017/745). • Hands-on experience managing product changes and ECO processes from a regulatory affairs perspective. • Familiarity with ISO 13485, ISO 14971, and other applicable medical device standards. • Experience supporting product development, design changes, and post-market regulatory activities. • Excellent organizational, analytical, and communication skills. • Strong written and verbal English communication skills. • Ability to work independently and effectively within a multidisciplinary environment. • Experience in the cardiovascular medical device field. • Experience with Class III and/or implantable medical devices. • Regulatory Affairs Certification (RAC) or equivalent professional certification. • Experience with additional international markets such as Canada, UK, Australia, Japan, or other global regions.

Description מחלקת משאבים לוגיסטיים מגייסת אחראית רגולציה וניהול פרויקטים תחומי אחריות ריכוז ומעקב אחר דרישות רגולטוריות החלות על הארגון ויישומן בפועל תיאום עבודה שוטפת מול משרדי ממשלה וגופים רגולטוריים (כיבוי אש, הגנת הסביבה, משרד הבריאות, משרד הביטחון ועוד) היערכות וליווי הארגון לקראת ביקורות, סקרים ועמידה בתקנים רגולטוריים ריכוז וניהול תהליכי בקרה, מעקב אחר משימות ועמידה בלוחות זמנים טיפול בדרישות רכש, הזמנות וחשבוניות, בשיתוף פעולה עם מחלקות רכש וכספים הפקת דוחות תקופתיים והצגת נתונים לגורמים רלוונטיים עבודה שוטפת מול ממשקים פנים־ארגוניים: הנהלה, תפעול, רכש וכספים ביצוע אדמיניסטרציה שוטפת, ניהול מסמכים, תיעוד נהלים וקבצים ארגוניים Requirements תואר ראשון בהנדסת איכות ניסיון בניהול פרויקטים- יתרון יכולת לעבוד תחת לחץ ולנהל מספר פרויקטים במקביל ניסיון בעבודה מול גופים רגולטוריים / משרדי ממשלה – יתרון יכולת עבודה עצמאית, סדר וארגון, ירידה לפרטים ועמידה בלוחות זמנים יחסי אנוש מצוינים ויכולת עבודה עם ריבוי ממשקים אנגלית ברמה טובה (קריאה, כתיבה ודיבור)

Description 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 30 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 want to make a difference in people's lives, we invite you to join us! The Regulatory Affairs Specialist works in the pharmacy division. Preparation of registration portfolios – including checking that contents are according to regulations, writing consumer manuals, designing packaging, attending to changes/renewal/updates including stringencies with manuals, and supporting all activities in the pharmacy division. Responsibilities Field of responsibility • Preparation of all types of submissions –products, renewals, variations, leaflets and packaging. • Responsibility for maintaining up-to-date product regulatory dossier. • Direct contact with the Ministry of Health and partners abroad. • Conducting regulatory and document checks. Requirements Required education and experience • Bachelors degree in pharmacy or other life science degree (chemistry/biology) • Previous experience of at least 2 years in regulatory affairs in Israel registration/renewal/variations of pharmaceutical products • High standard of English. • Extremely high standard of Hebrew. • Proficient in Microsoft Office - Outlook, PPT, Word, Excel. Required qualification • Accurate. • Ability to work under pressure. • Energetic and hardworking. • Trustworthy.

Job Description Summary The Senior Regulatory Manager provides CMC regulatory input and strategies to directly support development projects and marketed products within Pharmaceutical Diagnostics. The key responsibility of Senior Regulatory Manager is to develop and maintain the Quality sections of the product dossiers throughout the entire life cycle of a product (Module 2.3 and Module 3). GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Key Responsibilities include • To provide CMC related strategic regulatory input for the assigned projects/products. • Build, or provide input to, submission strategy documents by defining variation type, data required to support submission, and submission documents required for the submission package. Review and approve published output. • In conjunction with the Global Regulatory Lead (GRL), guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted. • Review and, if necessary, write and edit individual CMC submission documents/CMC dossier sections to support regulatory submissions. • Maintain registration tracking information and assist in the development of good document management practice standards. • Work closely with global RA and, regional RA’s to address questions from regulatory authorities. • In support of key brand CMC variations, proactively provide CMC related regulatory advice and assessment of impact to product dossiers. Advise project teams accordingly. • To support QA during audits and inspections as required. • To keep oneself updated on CMC related guidelines. Qualifications/Requirements • Bachelor's Degree and 6+ years of experience. • Experience in a diagnostic, pharmaceutical, or medical device industry. • Ability to prioritize, plan & evaluate deliverables to established strategic goals. • Demonstrated experience of operating in a highly-regulated environment. Capable of applying analytical skills in a CMC regulatory environment. • Demonstrated knowledge & experience in scientifically related field e.g. pharmaceutical sciences, chemistry and analytical sciences. • Experience in electronic document management and Quality management systems. • Knowledge of international CMC regulatory requirements. Desired Characteristics • Master's Degree • Experience in pharmaceutical CMC regulatory or QA environment particularly with experience with injectable diagnostic or pharmaceutical products. • Has experience working within a matrix organization and has strong interpersonal and influencing skills to work across disciplines. Has the capability to influence managers and help drive decisions at a project level. • Experience with Veeva RIM or other registration tracking tools. • Demonstrated experience of prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. • Strong problem solving and negotiation skills. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

For U.S. based positions only, the pay range for this position is $106,400.00-$159,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No Application Deadline: October 31, 2026

About Aidoc Aidoc is the market leader in healthcare AI and has developed the world's largest clinical frontier model, supporting nearly 50 million patients each year. Aidoc is deployed in more than 2,000 medical centers worldwide. Since our founding in 2016, Aidoc has raised over $500 million and achieved a record number of FDA-cleared solutions. Medical diagnosis is hitting a breaking point, where the number of physicians hasn't kept up with the rapidly growing patient load. This leads to misdiagnosis and treatment delays that result in hundreds of thousands of deaths every year. Aidoc assists clinicians by precisely highlighting diseases directly on medical images, preventing misdiagnosis and ensuring that urgent patients receive the immediate attention they need. About this role We’re seeking a Regulatory Affairs Specialist to join Aidoc’s Regulatory team. In this role, you will support regulatory activities throughout the software development life cycle, including regulatory assessments, world wide registrations, regulatory submissions, and regulatory operations — ensuring our products meet international requirements and industry standards. Your expertise will directly advance the compliance, safety, and successful market access of cutting-edge AI healthcare solutions. Responsibilities • Regulatory Impact Assessments: Lead regulatory assessments of software changes and product enhancements, evaluating their impact on existing approvals, determining global regulatory requirements, and developing strategies to ensure continued compliance while enabling innovation. • Global Regulatory Submissions & Market Expansion: Own and drive end-to-end regulatory submissions and product registrations across international markets, including Canada, Australia, Brazil, and other key regions. Lead the preparation of submission dossiers, manage interactions with regulatory authorities, and respond to regulatory queries to secure timely market authorizations and support global business growth. • Product Labeling: Lead the creation, review, and maintenance of product labels in accordance with applicable regulatory requirements across global markets. Manage labeling updates, localization, and translation activities to ensure accuracy, consistency, and compliance throughout the product lifecycle.Promotional & Marketing Material Review: Partner with Marketing, Product, and Commercial teams to review and approve promotional, marketing, and customer-facing materials, ensuring that product claims are accurate, appropriately substantiated, aligned with authorized intended uses, and compliant with applicable regulatory requirements. • Write, update, and maintain technical files for class I and Class IIa products • Perform Regulatory operations activities, including handling significant administrative responsibilities related to global registrations and technical processes such as updating databases, dashboards, and trackers diligently. • Stay updated on new and changing regulations. • Translate regulatory requirements into actionable processes, enhancing efficiency, compliance, and product quality across the organization. • Cross-functional Collaboration: Work closely with SW engineers, data scientists, and product teams to identify testing requirements, troubleshoot issues, and ensure regulatory Compliance. Requirements Education & Experience • Bachelor’s degree in Engineering, Life/Exact Sciences, Quality Assurance or Law. • 1-2 years in regulatory teams within the medical device industry, preferably with SaMD (software as a Medical Device) - a plus. • Interest or background in computer science or AI - a plus. Skills & Qualities • Structured thinker with the ability to read and implement regulatory guidance and standards. • Analytical skills and data-driven decision making. • Exceptional project and program management skills. • Ability to work independently with minimal supervision. • Detail-oriented, proactive, and accountable. • English proficiency equivalent to a native speaker, with excellent verbal and written communication • Collaborative, team-oriented mindset with a passion for learning and growth. Our Perks: • Be part of something big - using cutting-edge technologies to transform the Healthcare industry (while saving patients’ lives) • We work in a hybrid model, with our new offices located at 34 HaMasger Street in Tel Aviv and parking for employees. • Amazing and healthy breakfasts and lunches prepared daily by our personal chef! • Stocked up kitchen & meal card • Wellness: Aidoc employees-only gym, plus Pilates, Yoga, and functional workouts classes. • Amazing culture - collaborative, transparent & fun! • Attractive compensation package & benefits Aidoc is deeply committed to creating an inclusive workplace, and to the principle of equal opportunity for all individuals. We prohibit discrimination and harassment based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other status protected by law.