Head of Product at Vital Signs Solutions
Cambridge, England, United Kingdom -
Full Time


Start Date

Immediate

Expiry Date

20 Sep, 25

Salary

0.0

Posted On

21 Jun, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Software, Ivdd, Accountability, Chemistry, Entrepreneurship, Surface Chemistry, Technology, Communication Skills, Iso, Regulations

Industry

Pharmaceuticals

Description

JOB SUMMARY:

We are a high-growth digital in-vitro diagnostic start-up looking for a Head of Product to join our expanding team. You will be responsible for transitioning products from R&D to production to launch and will manage the laboratory operations at our QMS-13485 regulated lab in Cambridge. You will be a member of the executive management team working closely with the CEO to plan manufacturing strategy, operations and drive company growth. You enjoy working in a fast-paced dynamic environment and have a passion for digital technologies.

QUALIFICATIONS & EXPERIENCE REQUIRED

  • Minimum 10 years experience working in manufacturing within diagnostic or medical device companies
  • Minimum 5 years management experience, ideally managing a commercial laboratory
  • Proficiency in quality systems (ISO 13485), associated documentation and processes
  • Excellent knowledge of the in-vitro diagnostic industry and regulations (IVDD and IVDR)
  • Experience in tech transfer from R&D setting
  • Experience in establishing and managing supply chains
  • Experience in lateral flow device manufacturing a plus
  • Experience of software as a medical device (SAMD) a plus
  • Background in chemistry, particularly surface chemistry, a plus
  • Strong communication skills
  • Passionate about technology, healthcare and entrepreneurship
  • Experienced in working in cross-functional teams
  • Driven, motivated and organised
  • Working independently with a high level of accountability
Responsibilities
  • Manage the laboratory operations
  • Manage a team of production scientists
  • Provide scientific insight, direct research to solve scientific problems
  • Responsible for the technology transfer of production from R&D to production
  • Responsible for supply chains and manufacturing
  • Responsible for the completion of raw material specifications, in-process and out-sourced QC documentation and verification / validation processes in partnership with QA/RA director
  • Ensure compliance of laboratory with QMS-13485
  • Own the company’s manufacturing strategy and plan
  • Responsible for scaling prototypes to higher launch volumes
  • P&L responsibility for manufacturing function
  • Monitor the industry landscape with a particular focus on incremental innovations applicable to our products
  • Responsible for the life-cycle management of existing product
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