Vigilance Specialist for Medical Devices (BB-EC006)

Found in: Neuvoo Bulk DK


Job Description

One of our missions in Agilent is to help our customers around the world to fight cancer and other life-threatening diseases. We aim at providing the best solutions to ensure accurate and early diagnosis, and to improve treatment and enhance survival rates. This is your chance to contribute!

We are looking for a Vigilance Specialist to help us improving the quality of our Pathology products, by providing local and regional support for our vigilance activities with both, internal stakeholders as well as external stakeholders, such as subsidiaries, distributors, authorities, notified bodies or legal partners of Agilent products.

You will be part of a great team and have direct responsibility for the preparation, execution and follow up of Recalls/Field Safety Corrective Actions (FSCA), throughout the entire process.

Furthermore, you will be working closely with relevant internal stakeholders in RA, R&D, QA, Service/Sales, Production, Marketing, etc., ensuring an effective and efficient execution, in accordance with internal requirements and external regulatory requirements.

In this role, you will be responsible for:

  • Support the Enterprise Vigilance team with local coordination, including organizing and facilitating initiation and execution of field actions/recalls, in a timely manner.
  • Involved in Corrective and Preventive Actions (CAPA) activities related to vigilance and complaints.
  • Coordinate with Product/Design responsible SME's in regard to technical product insight and act as a link throughout the vigilance activities.
  • Follow up on Authority requests.
  • Communicate to Pathology/Diagnostic stakeholders incl. direct and indirect sales.
  • Provide status reporting to key stakeholders.
  • Ensure efficient and timely customer communication.
  • Additionally, you will team up for:

  • Process improvements projects.
  • Local activities supporting product investigations and vigilance documentation in accordance with procedures and regulatory requirements.
  • Support post market surveillance.

  • Qualifications

    Your profile:

  • Experience with vigilance documentation/activities and CAPA, from both a Quality Assurance (QA) and Regulatory perspective.
  • Science degree or related technical degree, or experience from a similar job.
  • Good understanding of applicable regulatory requirements and in Quality System Standards. E.g. ISO 13485, FDA CFR 21 Part 803, 806 and 820 and similar global regulations, preferably including IVD/Medical Device legislation in the USA (MDR) and the EU (MEDDEV).
  • Experience in interactions with authorities, stakeholders, and regulatory bodies.
  • Experience with post market products.
  • Fluency in English, oral and written, is a requirement for this role.
  • Good planning, communication and stakeholder management skills.
  • Capable of working both, independently and in a team setting.
  • Result oriented and ambitious.
  • Adaptable and enjoy working in a high pace environment.
  • We offer:

  • Training and development opportunities.
  • A commitment to work/life balance.
  • A company with values around innovation and contribution, uncompromising integrity, trust, respect and teamwork, speed, focus, and accountability.
  • The diversity of cultural and individual perspectives held by our employees and their commitment to inclusion.
  • Questions:
    For questions about the position, please contact hiring manager Fouad Channir on +45 5162 8739 or Recruitment Partner Tinne Bigum on +45 2933 6930.

    calendar_today1 day ago

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    location_onGlostrup, Denmark

    work Agilent

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