לוח משרות דרושים רישום / רגולציה רפואית משרה מלאה

What youll do
As Manager, Regulatory Compliance, Israel you will deliver on the regulatory engagement strategy for our company in Israel. You will maintain our licensing responsibilities and coordinate with all internal and external parties as necessary to ensure compliance through the communication of regulatory requirements, cross-functional collaboration to productize solutions and offerings, implementation and execution of processes, filing of all requisite reports, renewal of registrations and licenses, end-to-end management of regulatory examinations, and interfacing with our regulators on ad-hoc inquiries. You will analyse new and existing products and provide guidance to ensure that our 2LOD controls are fit for purpose and comply with regulatory obligations and guide the first line business to enable the maturity of both customer-facing and internal back-office processes and product features.
Responsibilities:
Support the company Groups expansion by managing the regulatory compliance components of licence authorisation processes
Act as a key stakeholder in relation to licence applications, business plan updates and information requests between our company and our regulators
Ensure that our regulatory compliance and integrity risk reporting obligations are maintained in the region
Support and / or manage on-site exams and inspections (in collaboration with our LRC colleagues)
Advise the business with respect to regulatory change initiatives with a particular focus on how to effectively manage compliance risk attached to new laws and regulations in the jurisdictions we operate
Develop policies, processes and provide advice in relation to regulatory risk obligations that exist within the 1st line business
Manage regulatory compliance risk within the company Risk Management Framework and associated escalation process (inc. the Group Risk Committee)
Advise the business in relation to conduct risk and ethics matters (where appropriate) relating to our financial services licences
Deliver the Compliance Monitoring Program; Conduct targeted and thematic reviews on a wide range of topics to ensure appropriate organisational maturity
Deliver the company Groups Compliance Training for employees and conduct ad-hoc training to specific business areas as required
Conduct Proactive Special Ops projects to unlock business or operational issues to enable our company to achieve its strategic goals more rapidly.

We are looking for an experienced Global Manufacturing Program Manager to join our team. This role involves managing complex programs from planning through full implementation, including knowledge transfer, production infrastructure setup, and compliance with regulatory and logistical requirements.
* Lead complex programs for establishing manufacturing and maintenance sites abroad, from planning to full execution
* Drive knowledge transfer processes to international teams
* Establish and implement production lines, processes, and operational procedures
* Collaborate with cross-functional teams, including Engineering, Operations, Procurement, Logistics, and international stakeholders
* Manage local and international suppliers and subcontractors
* Ensure compliance with quality standards, regulatory requirements, and security protocols
* Oversee project timelines, budgets, and risk management

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

Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
Key Responsibilities:
Daily duties include supporting the project team (R&D, SQA, Product, System and so on) during the development of a project. Our engineers review each design input and output deliverable throughout the development process and resolve compliance impediments as they arise. As a senior engineer the candidate will be responsible for defining two major evolving components in our work:
Implementing AI in our processes - What are the regulatory requirements for implementing AI in a medical device and how to implement it in our development lifecycle.
Cybersecurity work instructions in compliance with the new FDA guidance, train the various teams on the guidance and its implications to our process, and establish best practices for supporting post market vigilance.

In this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities
Actively contribute in the development of regulatory strategies for software and product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities and global strategy for product launch.
Define and prepare document packages for US FDA regulatory submissions, EU MDR Technical Files, and international packages.
Assess product changes and their global regulatory impact.
Ensure timely license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Monitor and document post marketing activities, analysis of trends, vigilance processes.
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changes