REGULATORY AFFAIRS SPECIALIST WITH HUNGARIAN LANGUAGE (FLEXIBLE LOCATION CZ/SK/HU)

The Medical Devices segment produces a broad range of innovative products used primarily by health care professionals in the fields of orthopaedics, neurovascular, surgery, vision care, infection prevention, cardiovascular disease, sports medicine, and aesthetics.
This segment is comprised of One Ethicon, DePuy Synthes and Cardiovascular & Specialty Solutions.
Regulatory Affairs Specialist with Hungarian language (Flexible location CZ/SK/HU)   Location.
CZ/SK/HU In this position, Regulatory Affairs Specialist will be responsible for regulatory compliance of medical devices distributed in CEE Central Region market with the main focus on Hungary.
The role will assure timely notifications of medical devices and all tasks connected with.
Provide support in RA matters to ensure compliance and business continuity.
The responsibilities & the impact YOU will have.
·       Ensure regulatory clearance of medical devices being in product portfolio of J&J MDs within timelines.
Coordination and preparation of product notifications and strategies.
Managing product submissions and communication with national health authority.
·       Provide regulatory support to tender management, health economics & reimbursement, business, customers and franchises.
·       Provide communication and updates to management regarding regulatory affairs and deliver RA trainings to local clusters.
·       Ensure timely communication and feedback on problems and events related to RA compliance.
·       Responsible for approvals in systems linked to job duties and maintaining RA databases.
·       Establish and keep relationships with business partners and internal/external RA groups (MD), health authority and franchises.
·       Support the Copy review process.
·       Monitor legislative situation, lead projects related to compliance and ensure that RA SOPs are updated and followed.
·       Support deployment of JnJ Standards into LOC QMS related to RA aspects.
·       Collaborating with J&J departments to coordinate development of procedures, documents and controls to ensure compliance in a timely manner.
Review and disposition document changes within areas of expertise per applicable procedures.
·       Perform other work-related duties as assigned by manager.
Qualifications We would love to hear from YOU, if you have.
·       Demonstrable knowledge of Regulatory, understanding of Medical Devices environment.
·       At least 1 year experience in Regulatory Affairs environment.
·       Excellent interpersonal skills - build and maintain relationships with internal and external partners.
·       Detailed planning and execution to achieve accurate and timely results.
·       Sense of importance and mission of the role.
·       Advanced knowledge of Microsoft Word, Excel and related functions.
·       Excellent organizational skills and attention to detail.
·       Excellent communication skills – both written and oral, and the ability to collaborate closely with internal and external parties.
·       Excellent Hungarian and English, Czech / Slovak language advantage ·       Ability to understand cross-enterprise data flow and system.
·       The embodies values, ethic and trust.
This is what awaits YOU at J&J.
·       An opportunity to be part of a global market leader.
·       A dynamic and inspiring working environment.
·       Many opportunities to work on challenging projects and assignments.
·       Possibilities for further personal as well as professional development.
·       Many employee benefits.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we in Johnson & Johnson are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential.
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