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Regulatory Affairs

Regulatory Affairs Junior Specialist

  • Job Title Regulatory Affairs Junior Specialist
  • Function Regulatory Affairs
  • Sub Function Regulatory Affairs
  • Location Prague, Czech Republic
  • Date Posted
  • Requisition Number 2206090381W
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Description

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 Junior Specialist, Region Central CEE

Location: Prague, Czech Republic

We have an immediate opening for a Regulatory Affairs Junior Specialist. This position will join our hardworking regulatory team and report directly to the Regulatory Affairs Lead, providing regulatory support to CEE region MedTech company. The main focus of the RA Specialist will be on preparing and submitting regulatory documents and maintaining databases for the Czech Republic, Slovakia and Hungary. RA Specialist will also provide support in RA matters to ensure compliance and business continuity and will be located in Prague.

The responsibilities & the impact YOU will have:

  • Responsibility for updates and approvals in systems linked to job duties.
  • Maintaining RA databases (internal and global), including data entry, updates and retrieval.
  • Assistance in preparation and submission of regulatory documents and in product notification.
  • Providing RA support to Tender team, Health Economics & Reimbursement, Business, Distributors and Franchises.
  • Providing support during internal and external audits.
  • Managing and ensuring waste reporting to regulatory agencies.
  • Ensuring timely communication and feedback on problems and events related to RA compliance.
  • Effective collaboration and maintaining relationships with local colleagues, business partners, franchises and RA teams.
  • Providing support for administrative procedures as required.
  • Ensuring readiness of local Regulatory Affairs department.
  • Performing other work-related duties as assigned by manager.

Qualifications

We would love to hear from YOU, if you have:

  • At minimum Bachelor´s degree or equivalent – medical, technical, legal education advantage.
  • Excellent interpersonal skills.
  • Precise 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.
  • Strong analytical and organizational skills with attention to detail.
  • Excellent Czech and English communication skills.
  • 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. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

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We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.

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