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Regulatory Compliance Specialist

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Regulatory & Quality Assurance
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In this role you will ensure compliance with international regulations and company procedures by supporting the development, maintenance and improvement of Quality Systems affecting Hologic products distributed in the EMEA region

Supports external and internal audits of the QMS including interfacing with sites and regional competent authorities during all the steps of identifying, reporting and finalizing any audit nonconformance. 


Your main duties and responsibilities will be to:

  • Interpret and apply regulations to existing Hologic products to ensure compliance with these regulations in all OUS sites, dealers and distributors
  • Acts as a QA mentor on interpretation and application of regulations, laws, guidelines, standards and initiatives to Hologic Employees, dealers and distributors
  • Serves as a Regulatory Compliance Interface to other departments, partners and Regulatory Bodies  
  • Assists in the development, maintenance and continuous improvement of the QMS
  • Manages and coordinates activities associated with aspects of the Quality Management System including: 
    • SOP / WI  writing, process mapping, controlling and revising, as appropriate.
    • Review and assess document changes affecting EMEA procedures in accordance with internal procedures  
    • Responsible for document and record control in the QMS.
    • Archiving obsolete quality documents
    • Assist in Management Review meetings, including collecting and collating  data from different stakeholders and prepare presentation slides
    • Management of  Non-Conformance events, Corrections and CAPA’s
    • Participation in CAPA Review Board
    • Participation in Material Review Board, as required
    • Participate in SQMT (Supplier Quality Management), as required
  • Supports the external and Internal audit schedules including:
    • Performs Internal / Supplier / Distributor audits, as required
    • Follow up on audit actions 
    • Create monthly reports to regional management on the status of internal and external audits, open actions, overdue activities and future audits
    • Interact with regulatory agencies with regards to audits and responses until closure, as required
  • Develops, analyses, trends, maintains and reports corporate metrics
  • Participate in global quality compliance teams and support implementation of harmonized procedures, as required
  • Perform other related duties as assigned

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, preferably in a non-manufacturing environment
  • Has first  experience of performing internal audits
  • 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.)
  • Strong working knowledge of Microsoft Applications including Excel Word PowerPoint and Visio
  • Ability to effectively train other individuals to Quality System procedures and programs Ability to independently plan, execute, and/or problem solve moderate to complex situations.
  • Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Must demonstrate initiative, balanced assertiveness working as a team player.
  • Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel both in English and preferably another European Language
  • Ability to manage multiple projects
  • Ability to work in a changing environment and manage stress

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 20%

 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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