Laboratory Manager - Medical Devices

Salary and bonus: available upon application

Projectus are exclusively representing our global Medical Device partner, who are on the lookout for their next Laboratory Manager.

With consistently new projects coming onto site and huge investment, we are on the lookout for someone who can handle change, lead a team of around 5-10 people and work with various stakeholder groups.

Are you this person? Please read on…..

KEY ACCOUNTABILITIES

• Manage laboratory activities and ensure compliance onsite.
• Monitor regulatory changes affecting laboratory operations.
• Manage departmental budgets, KPIs, staffing, and operational priorities.
• Manage a team of 5-10 people, lead and develop through performance management, recruitment, training and coaching.
• Collaborate cross-functionally with Production, Supply Chain, R&D, and Process teams.
• Coordinate with regulatory authorities, notified bodies, and external laboratories.
• Represent during absence of the Site Quality & Regulatory Compliance Director

SKILLS/EXPERIENCE REQUIRED

• Life Science Degree background (ideally from Microbiology)
• Experienced in Cleanroom environments & clean lines
• Multiyear experience within laboratory management (at least 5+ years’).
• Strong knowledge of:
• • ISO 13485, MDR, FDA QSR, ISO 14971
  • Sterilization, biocompatibility, GMP and analytical laboratory standards
  • Audit processes and quality tools
• Must come from a people management background i.e. strong leadership, decision making and problem solving abilities
• Communication and stakeholder management skills.