Global Quality Regulatory Field Action Specialist

2 days ago


Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full time

We are seeking a highly skilled Global Quality Regulatory Field Action Specialist to join our team at Agilent Technologies in Denmark-Glostrup.

About the Job

The estimated salary for this position is between $80,000 - $110,000 per year, depending on experience and qualifications.

As a Global Quality Regulatory Field Action Specialist, you will be responsible for managing field action activities, leading strategy meetings, recalls, field notifications, and correction processes for medical and non-medical products. You will work closely with product investigation and CAPA teams to collect event information and document investigations.

You will also verify and check investigation summaries, create field action strategy, write field notices, and coordinate reviews with stakeholders. Additionally, you will report field actions to global Health Authorities, notified bodies, and interface with in-country teams to execute field actions.

This role requires strong analytical and communication skills, as well as the ability to work independently and collaboratively as part of a team.

Key Responsibilities:
  • Evaluate escalation information regarding field actions.
  • Assist business investigation teams with reviewing slide decks created for quality regulatory alignment meetings (QRAM) and field action committee meetings.
  • Escalate product quality issues where necessary from data gathered in post-market team meetings regarding potential field actions.
Requirements:
  • Bachelor of Science degree in Engineering or Scientific/Technical discipline or other relevant education.
  • Minimum of 2 years relevant professional experience in the MD/IVD, Pharma, or other related Life Science industry.
  • Minimum of 2 years working with remedial actions, such as field actions, field safety notices (FSN), or field safety corrective actions.

Please note that we are an equal opportunity employer and welcome applications from qualified candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected categories under all applicable laws.



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