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Senior Regulatory Compliance Specialist, EMEA

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Regulatory & Quality Assurance
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2489 Total Views
Thanks for your interest in the Senior Regulatory Compliance Specialist, EMEA position. Unfortunately this position has been closed but you can search our 209 open jobs by clicking here.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


We are looking for a candidate who has/can:


  • Bachelor or equivalent in a scientific discipline preferably biological sciences, life sciences or related discipline. 
  • Experience in quality and/or compliance role within medical device or pharmaceutical industries.
  • Certification of Lead Auditor and or Certification of Internal Auditor
  • Has first experience interfacing with competent authorities regarding audit activities and resolution of observations.
  • Has good  knowledge of applicable regulations and standards related to medical devices industry  (ISO 13485, MDR/IVDR  etc.)
  • Working knowledge of MS Word and Excel
  • Excellent writing skills

  • Excellent verbal communication skills
  • Ability to communicate effectively with a diverse team member and guest population
  • Ability to analyze and evaluate unusual situations and make sound judgments
  • Ability to analyze data, establish facts and draw valid conclusions
  • Ability to obtain, assemble, organize and evaluate information
  • Ability to present moderate to complex concepts in a clear and concise manner
  • Ability to provide coaching and guidance to staff
  • Ability to maintain focus and perspective on large scale goals and objectives
  • Ability to maintain professionalism and composure
  • Ability to maintain confidentiality
  • Ability to keep integrity and high ethics
  • Ability to accept constructive criticism
  • Team player

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

       Regularly required to sit

       Regularly required to use a computer keyboard, mouse, and monitor  

       Regularly required to talk and hear

       Occasionally required to walk to meeting locations  

       Required to use close vision and adjust focus  

 

Your work environment:

 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Work is performed primarily in an office environment
  • Travel expected up to 30%

 Accountability:

  •  Actions taken by employees in this position have financial impact on end results of the department and the company

Hologic offers a dynamic and innovative work environment along with excellent benefits that include bonus potential, stakeholder pension scheme, wellness program, life assurance and childcare vouchers.  

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