Deputy Head of Notified Body and Managing Director
Intertek / Ekonomichefsjobb / Stockholm
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Vi hjälper våra kunder att se till att deras processer, produkter och system är säkra och håller den kvalitet som både myndigheter och kunder världen över förväntar sig. Det gör våra 42 000 medarbetare världen över genom att inspektera laster och fabriker, testa och certifiera allt från leksaker till medicinteknik, granska underleverantörer, certifiera ledningssystem, analysera livsmedel, oljeprodukter och kemikalier och utvärdera batterilösningar för elfordon. Bland mycket annat. Vi gör världen lite säkrare, helt enkelt!
Bringing quality and safety to life
Join the exciting journey of the Medical Device Notified Body into the MDR!
Reporting to the Head and MD of the Notified body, responsibilities of the role includes:
• Act as Head of Notified Body when required
• Accountable for compliance for Notified Body and related branches, to relevant external standards including but not limited to:
• ISO17021 Accreditation
• EU Medical Device Directives and Regulations (e.g. 93/42/EEC)
• Other programme specific requirements (e.g. ISO13485, MDSAP, TCP)
• Accountable for compliance for Medical Notified Body AB 0413
• Support in the establishment of a sales structure and strict rules on which NB codes can and cannot be sold
• MDR Joint Assessment to be prepared and completed successfully leading to successful accreditation in spring 2019, latest
• Leverage scale through delivering shared service scheduling and processes, cost synergies through the application of MDR.
• Lead the team through change:
• Robust performance people, talent management and engagement
• Develop the organizational culture and focus management more on customer processes (good to great journey and our customer promise) and employee behaviour (10X culture).
• QHSE (Quality, Health, Safety, Environment) - ensure that QHSE processes are established, implemented and maintained, law requirements and local regulations
• Responsible for the activities and decisions taken by the notified body, including contractual agreements
• Responsible for the delegation of authority to personnel and/or committees, where necessary
• Responsible for gathering all necessary inputs and convening the Quality Management Review meeting as per the requirements of the Management Review Process
• Ensure the internal audits are conducted at least once annually on the entire certification system
• Overall responsible for all conformity assessment activities in relation to devices
• Ensure the Notified Body has adequate resources for conformity assessment activities
• Accountable for ensuring confidentiality and independence from commercial and other interests, and raising any existing or prior association with clients to line manager immediately
• Support and coach NBMT with technical input
Other Skills
• The role holder should possess either an appropriate degree, college degree or other qualifications and/or experience in either Health Science, Engineering or Quality/Regulatory disciplines related to the Medical Device or Pharma industry sectors
• 5+ years experience in Management on a global or multi-site scale
• 5+ years' experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories
• Extensive knowledge of the EU Medical Device Directives and Regulations and Quality Management Systems
• Has a keen eye for detail and is focussed on delivering accurate results within agreed timeframes
• Operates ethically with the highest degree of professional integrity.
What we offer
Intertek is a safe workplace with collective agreements, benefit package with pension, health care contributions and parental leave allowance. We have flexible working hours and encourage a good working climate and satisfied employees.
The role is full time and based in Stockholm, Sweden.
Submit your application with resume and cover letter today, or as soon as possible. If you have any questions regarding the position, please contact Head of Notified Body Nakisa Harmes,
nakisa.harmes@intertek.comVaraktighet, arbetstid
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Publiceringsdatum2018-10-29ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-12-15
Klicka på denna länk för att göra din ansökanFöretagIntertek
AdressIntertek
Torshamnsgatan
16422 Kista
KontorsadressTorshamnsgatan
Jobbnummer 4428334
Observera att sista ansökningsdag har passerat.