Join the exciting journey of the Medical Device Notified Body, heading up a Notified Body during a maternity cover of 12 months!
Reporting to the Executive Vice President of Europe, responsibilities of the role includes:
- Heading up the Notified Body and a temporary Managing Director for 12 months
- 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
- Lead the team through change
- Robust performance people, talent management and engagement
- Develop the organizational culture and focus management more on customer processes and employee behaviour
- QHSE (Quality, Health, Safety, Environment)
- 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
- Support and coach management team
What do you need to succeed?
- 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
- 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 for a period of 12 months 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 via our reception on 08-750 00 00.