Regulatory Affairs Director, Europe

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Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around us.

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.

Agilent is seeking a highly skilled, motivated and customer focused professional leader to join our European team in Denmark.

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
  • We Offer:

  • An opportunity for you to make a significant impact in a world-class company and develop your skills
  • An exciting opportunity to influence and develop new processes and shape this new position and its function within the company
  • A commitment to you having a healthy work/life balance
  • A leadership role among passionate colleagues, in a growth orientated and inclusive environment. You will become part of a caring and fast paced environment, built on integrity, sharing and trust
  • Agilent offers core global benefits to all staff - but in addition to these, the DK business offers Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Holiday, Physiotherapy and even an Art Club!
  • We will make sure you get all the training and development opportunities you need to become the best in your field!

    Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment 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.

    Travel Required

    Occasional

    Schedule

    Schedule:Full time

    Shift

    Day

    Duration

    No End Date

    Job Function

    Quality/Regulatory

    Skriv i din ansøgning, at du fandt jobbet på ofir.dk


    Regulatory Affairs Director, Europe

    Job Description

    Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around us.

    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.

    Agilent is seeking a highly skilled, motivated and customer focused professional leader to join our European team in Denmark.

    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
  • We Offer:

  • An opportunity for you to make a significant impact in a world-class company and develop your skills
  • An exciting opportunity to influence and develop new processes and shape this new position and its function within the company
  • A commitment to you having a healthy work/life balance
  • A leadership role among passionate colleagues, in a growth orientated and inclusive environment. You will become part of a caring and fast paced environment, built on integrity, sharing and trust
  • Agilent offers core global benefits to all staff - but in addition to these, the DK business offers Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Holiday, Physiotherapy and even an Art Club!
  • We will make sure you get all the training and development opportunities you need to become the best in your field!

    Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment 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.

    Travel Required

    Occasional

    Schedule

    Schedule:Full time

    Shift

    Day

    Duration

    No End Date

    Job Function

    Quality/Regulatory

    Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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