Senior Project Engineer (Quality & Regulatory)

Job description

Senior Project Engineer (Quality & Regulatory)

Medical Device

Contractor - 6 to 12 months

This position is responsible for planning, directing and coordinating concurrent projects/programs within the Quality & Regulatory function. It is chiefly focused on governance, business and stakeholder engagement, scope management, change management, strategic planning, communications and project management through delivery.


  • Fluent business English speaker with good interpersonal, excellent communication and presentation skills
  • Minimum Bachelor’s Degree or equivalent qualification in a scientific discipline.
  • At least 3 years’ experience in working through Project/Program Management, in Regulatory, Quality or Medical Device initiatives, with demonstrable evidence of effective execution and sustained compliance to regulations and standards.
  • Experience in handling and delivering multiple projects (2 or more concurrently).
  • Driven projects in a complex and multi stakeholder environment.
  • Experienced in working with cross-functional teams such as Quality, Regulatory, Purchasing, Supply Chain, Finance, Marketing, etc.
  • Experience of working with global teams with effective project execution.
  • International exposure and experience, operating across multiple time zones.
  • Experience of working with GMP compliant sites and achieved effective delivery with TPMs and in-house manufacturing sites.
  • Familiar with ISO13485 quality system, EU in-vitro Diagnostics Regulation (IVDR) and EU Medical Device Regulations (MDR)



  • Knowledge of MDR, IVDR, Post Market Surveillance, Vigilance, and Complaint processes a distinct advantage.
  • PMP or equivalent certification in Project Management.
  • Strong technology awareness in line with technologies in use across the Division (e.g. MS Projects, MS Office, MS Visio, SharePoint and MS Teams).
  • Experience of leading and implementing change initiatives and active stakeholder management.
  • Experience of working with culturally diverse groups of people, able to communicate effectively at all levels of the business, and with both technical and non-technical people, adapting approach to suit the audience.
  • Attention to details by documenting meetings, action items and objectives.
  • Additional languages 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.