לוח משרות דרושים מנהל רגולציה

Exciting opportunity to be part of Imaging Informatics regulatory team. Imaging Informatics
business unit includes solutions for radiology and cardiology. From enterprise imaging, PACS, and
workflow orchestration, through to a full suite of solutions for the cardiovascular workflow, we deliver
optimized imaging service lines that enable enterprise imaging across sites, specialties and technologies
to simplify medical image management, enable effective collaboration and enhance patient care. This role
will focus on radiology regulatory activities.


Responsibilities:
Represent regulatory affairs at the Radiology Informatics leadership team
Through end-to-end regulatory processes, ensuring safe and effective products are brought to
market, on time, and sustained throughout life cycle via compliant, innovative regulatory
strategies
Manage day-to-day functioning of radiology regulatory team ensuring effective and efficient
execution
Provide critical input on regulatory risk assessments to support portfolio selection and post
market decision making
Build proactive, strategic relationships with external stakeholders (Notified Bodies, FDA,
Competent Authorities, etc.) to ensure that requirements are known early during strategy
development, which enables fast market access with the current portfolio in connection with
future innovations.
Lead and enable strong cross-functional partnership between regulatory affairs and all key
stakeholders including R&D, Product Management, Quality, Clinical Affairs, and other functions at
all levels within the business, and the local Regulatory Affairs teams in the market
organization.
Mentor and develop regulatory talent and competency to ensure strategic engagement and
execution excellence

Alma, a Sisram Medical company, is a global leader in medical-aesthetic technologies, with over 25 years of experience in energy-based devices (EBD). Over the years, Alma has evolved into an integrated aesthetic and wellness ecosystem that combines medical devices, injectables, diagnostics, and personalized skincare. The company operates in a dynamic, innovation-driven environment, merging advanced technology with deep clinical understanding to create holistic solutions for aesthetic clinics. Alma’s headquarters are in Caesarea, Israel, with business operations in more than 100 countries worldwide. Key Responsibilities A. Risk Management – Mandatory / Top Priority
* Perform and maintain risk management activities according to ISO 14971 across the full product lifecycle.
* Develop, update, and maintain Risk Management Files (RMF), including:
* Perform FMEA (all types)
* Hazard identification
* Risk analysis and risk evaluation
* Risk control measures and mitigation strategies
* Residual risk assessment
* Benefit–risk analysis
* Lead and actively participate in risk analysis activities and meetings (e.g. FMEA, FTA, Hazard Analysis).
* Ensure technical risks specific to energy-based systems are properly identified, documented, and controlled, including (HW, SW, Clinical etc.):
* Verify, document, and maintain evidence of risk control effectiveness.
* Integrate design data, design/engineering changes, service feedback, complaints, and post?market information into ongoing risk evaluations.
* Provide risk-related input for:
* New design project
* Design changes and product modifications
* CAPAs
* Product improvements
* Regulatory submissions and updates
* AE – Adverse Events
* PMS activities B. Regulatory, PMS & Adverse Event Responsibilities (Core Responsibility)
* Perform post?market surveillance (PMS) activities in accordance with global regulatory requirements, including data collection, analysis, and documentation.
* Conduct adverse event (AE) and complaint assessments, including:
* Initial assessment and classification
* Support and execution of investigations
* Risk evaluation and impact assessment on product safety and performance
* Reporting to regulatory authorities
* Ensure integration of AE, complaint, service, and PMS data into risk management files, maintaining continuous risk evaluation.
* Perform trend analysis of complaints, adverse events, and post?market data to identify safety signals, emerging risks, or systemic issues.
* Prepare and maintain PMS documentation, including contribution to and preparation of PSURs, with clear linkage to risk management outputs.
* Participate in and support regulatory assessments and submissions.
* Ensure all PMS, AE, and risk-related documentation is accurate, traceable, and audit?ready.
* Participate in internal and external audits related to risk management, vigilance, and PMS activities.

Subsidiary:
Alma LTD

This position will be based in our office in Israel (Airport City), reporting to HR Director.

Job Description

We are seeking a Project Manager to lead the Regulation and ISO domain within the company in Israel. The role includes full responsibility for managing, leading, and implementing regulatory processes and ISO standards, working closely with all company departments and external consultants.

This is an independent role with broad cross-functional interfaces, involving process design, monitoring and control, leading internal and external audits, and continuous improvement of procedures and workflows.

In addition, the role will include leading cross-organizational and operational projects according to company needs.

Key Responsibilities

Regulation & ISO

Overall responsibility for the companys compliance with relevant regulatory requirements.
Lead and manage ISO certification and maintenance processes.
Draft, update, and implement procedures and work processes.
Prepare for and accompany internal and external audits.
Ongoing work with regulatory authorities and auditing bodies.
Risk management, gap analysis, and implementation of corrective actions.

Alma, a Sisram Medical company, is a global leader in medical-aesthetic technologies, with over 25 years of experience in energy-based devices (EBD). Over the years, Alma has evolved into an integrated aesthetic and wellness ecosystem that combines medical devices, injectables, diagnostics, and personalized skincare. The company operates in a dynamic, innovation-driven environment, merging advanced technology with deep clinical understanding to create holistic solutions for aesthetic clinics. Alma’s headquarters are in Caesarea, Israel, with business operations in more than 100 countries worldwide. · Prepare, compile, submit, and maintain global regulatory submissions. · Support regulatory activities across the product lifecycle, including new product introductions, design changes, software releases, labeling updates, and change control processes. · Perform regulatory impact assessments for product changes and ensure timely updates to technical documentation and risk management files. · Maintain regulatory records, technical documentation, declarations, and evidence of conformity per applicable regulations and standards. · Review and approve labeling, IFUs, UDI and promotional materials to ensure compliance. · Provide regulatory guidance to R&D, Quality, Operations, Marketing, and Clinical teams; · Participate in audits/inspections and interface with regulatory bodies/certification bodies as needed.

Subsidiary:
Alma LTD

we are looking for a Senior Regulatory Affairs Specialist Medical device.
The Senior RA specialistwill be responsible for leading global market expansion and new product introductions for Class I, Class II (US) and Class IIa (EU) medical devices. Responsibilities include planning and executing regulatory submissions for the US, EU, and other international markets, creating and maintaining technical files, managing complaints, overseeing change activities, and ensuring post market compliance. The role collaborates with cross functional teams - including QA, R&D, Clinical, Manufacturing, Operations, Marketing, and Commercial - to ensure compliant efficient, and timely market access throughout the product lifecycle, including sustained compliance.
Responsibilities:
Market Expansion & Global Regulatory Registrations:
Prepare and maintain global regulatory submissions (e.g., India, Australia, Singapore, Mexico) and author full submission packages. (e.g., EU MDR Annex II/III TD, US 510(k), ANVISA, SFDA, NMPA).
Monitor regulatory changes and ensure sustained compliance across all markets, including labeling, UDI, and post-market updates.
Conduct jurisdiction -specific impact assessment for product changes and manage global propagation of design, labeling and UDI updates.
Collaborate with R&D, Operations, Marketing, and product teams throughout new product development and commercialization to ensure regulatory alignment
Review technical documentation and ensure compliance across the full product lifecycle
Serve as the QA/RA point of contact for cross-functional programs and regulatory-related initiatives.
Maintain existing registrations, manage renewals and variations, and oversee global portfolio compliance.
Develop and execute global regulatory strategies for new market entry (US 510(k), EU MDR, Canada MDL, LATAM, APAC, MEA), including interpret country-specific requirements, identification of testing and labeling needs, and creation of submission roadmaps.
Lead pre-submission meetings and manage interactions with health authorities and notified bodies.
Ensure compliance with ISO 13485, 21 CFR 820, EU MDR, and applicable country regulations.