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What you will be doing:
* Be part of the company management team with responsibility to lead regulatory strategy planning for company products.
* Responsible to prepare regulatory submissions across all products and platforms as needed.
* Review and present to the management and CEO regulatory updates and status reports.
* Responsible for the development and preparations of regulatory submissions across all products and platforms as needed.
* Be the point of contact for all regulatory inputs and deliverables from headquarters for product and clinical research submissions.
* Responsible for maintenance of product regulatory files and registrations (NoC, registration renewals, annual reports etc.).
* Provide regulatory support to R&D - project regulatory requirements, assure adherence to the regulatory path and resolve emerging conflicts with regulatory requirements.
* Responsible to provide regulatory support to manufacturing, logistics, engineering, supply chain and sales teams.
* Responsible for regulatory assessment of customer complaints, reportability assessments and MDR’s to regulatory agencies.
* Act * as the person responsible for regulatory compliance (PRRC), responsible to ensure the following:
* The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
* All post market surveillance and reporting obligations are met, including reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions and analysis of vigilance data.
* For investigational devices projects , the statement referred to in Section 4.1 of Chapter II of Annex XV of the EU medical device regulation (MDR) is issued. * This is a joint responsibility with VP of Global QA, where VP RA is the main responsible for the above activities

Are you ready to power the future? we're a global leader in smart energy technology, with over 4,000 employees, offices in 34 countries, and millions of installations worldwide. Our innovative solutions include solar inverters, battery Storage, backup systems, EV charging, and AI-based energy management. We're committed to making clean, green energy the primary power source for homes, businesses, and beyond. With the growing demand for electricity, the need for smart, clean energy sources is constantly rising. We offer amazing opportunities to develop your skills in a multidisciplinary environment, covering everything from research and development to production and customer supply. Work with talented colleagues, tackle exciting challenges, and help create a sustainable future in an industry that's always evolving and innovating. Join us and be part of a company that values creativity, agility, and impactful work. What you will be doing:
* Order processing through continuous communication with customers, operations and sales managers.
* Ensuring an appropriate order flow according to organizational policies.
* Continuous communication with our worldwide departments, finance, sales operations, planning and sales.
* Troubleshooting in ordering processes and derivation of possibilities for enhancement.
* Contract signing process and manage follow up tables.
* Issue weekly reports, reflecting order statuses and financial aspects.
* Supporting the sales department with other administrative tasks, if requested.
Country:
Bulgaria
City:
Sofia

The Data Path HAL team is looking for an Embedded Software Engineer, to join us in building the next generation of networking products. Youll have the opportunity to work on the technologies that power the worlds largest cloud provider, in a dynamic, open, fast-paced environment.
Working in both pre-silicon and post-silicon activities defines the Data Path HAL team as a leading team in AWS software development.