Regulatory Affairs Director, Europe

Regulatory Affairs Director, Europe

Agilent Technologies

Glostrup, Denmark

Job Description

We are looking for a Regulatory Affairs Director to lead a team who thrives in a multifaceted environment, enjoys helping employees reach their potential, and encourages new challenges and opportunities to grow. In this role, you will lead a team of Regulatory experts in the EMEAI region ensuring Regulatory compliance, and acting as the Agilent Responsible Person for IVDR. If you are up for this challenge, then this role could be for you!

As the Agilent person responsible for IVDR, you will be a leader in the Global RA team, identifying solutions to potential gaps, implementing processes, and ensuring compliance to IVDR. You will ensure any changes to regulations that impact the region are communicated, and align with key partners on implementation of new requirements. As a member of the Agilent Global Regulatory Team, you will provide mentorship to the business teams on Regulatory requirements and ensure these are implemented following the One Agilent Quality processes.

Key Responsibilities

  • Act as the Responsible Person for all IVD businesses
  • Develop, implement, and train on new procedures or processes vital for IVDR Compliance as the Responsible Person
  • Enjoy leading, mentoring, and developing employees
  • Ensure compliance to Regulations pertaining to the EMEAI (Europe, Middle East, Africa, India) region, monitoring, advising of changes to regulations, seeing opportunities for improvement, and leading communications to key partners throughout Agilent
  • Establish, maintain, and supervise compliance activities related to RoHS, REACH, SCIP, WEEE, Packaging, Battery, and other relevant regulations
  • Act as the liaison to Regulatory authorities as needed
  • Participate in the Standards Committee, completing assessments and providing updates as needed
  • Facilitate requests from the Businesses on related needs for EMEAI region

Qualifications

  • Bachelor’s degree or equivalent preferably within a science field (Engineering, Chemistry) with a demonstrated ability working in regulated industry (medical devices and/or IVD products)
  • Proven Regulatory Affairs experience
  • A validated experience with managing, training and developing employees
  • In-depth knowledge of IVDD/IVDR Regulations
  • Working knowledge of Regulatory requirements for EMEAI country requirements
  • Knowledge and experience with Regulatory standards and compliance requirements
  • Proven leadership skills and ability to collaborate and work effectively in teams across different businesses, functions, and geographies
  • Excellent communication and problem-solving skills
  • Must be a self-starter with an ability and passion for motivating others

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EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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