Deputy Head of Notified Body, Vice VD

Medical Device, Stockholm

Do you like to be the next deputy head of a notified body.

Responsibilities

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:
o ISO17021 Accreditation
o EU Medical Device Directives and Regulations (e.g. 93/42/EEC)
o 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:
o Robust performance people, talent management and engagement
o 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.


For more information about the position, please contact Erik Düring at +46 708 999469 or during@rekryteringsspecialisten.se