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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.
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Confirmed an hour ago. Posted 22 days ago.

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