Join the exciting journey of the Medical Device Notified Body, heading up a Notified Body during a maternity cover of 12 months!
We formed our legal identity in July 2018 with the goal to be one of the certified Notified Body for medical devices in Europe. We have since then been in strong growth. We are looking for someone who will take the lead for this exciting journey when our current MD is on maternity leave, from March 2019 to March 2020.
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
- Accountable for compliance for Medical Notified Body (AB 0413)
- 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
- Support and coach management team
What we offer
- 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. Preferable experience from from consultant industry
- 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.
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.