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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.

Requirements

  • 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)

Desirable (NOT ESSENTIAL)

 

  • 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 

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