Convatec

Senior Biocompatibility Manager

Convatec

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

About the role

  • Manage and develop the biocompatibility team
  • Manages and allocates resource in line with project needs and priorities
  • Identifies training opportunities for the team towards continuous improvement
  • Ensures seamless and proactive collaboration with the project teams
  • Synthesises a development plan with each team member
  • Ensure the team has up to date knowledge of biocompatibility standards, techniques and protocols
  • Instills a positive working culture of collaboration in line with Convatec’s values and leadership behaviors
  • Deliver on biocompatibility for NPD, LCM and research projects
  • Foster cross functional collaboration and teamwork between the biocompatibility team and other teams
  • Lead on accurate project planning and timely execution in partnership with project teams
  • Work closely with program/project cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements
  • Evaluate and execute biocompatibility studies in support of programs dealing with our medical devices

Requirements

  • At least 10 years experience in biocompatibility assessments for NPDs and LCMs in territories including Europe and USA
  • Experience with complex FDA submissions and dealing with FDA queries and feedback is essential
  • 10 + years’ industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, related principles and industry standards
  • BSc or higher degree in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Microbiology, or Toxicology; advanced degree (MS or PhD) in these fields preferred
Benefits
  • Remote working from home with presence in the office based on business needs
  • Coaching and development opportunities for the team
  • Fostering collaboration with cross-functional teams
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
biocompatibility assessmentstoxicologyproject planningregulatory compliancebiocompatibility studiesNPDLCMFDA submissionsbiocompatibility standardsbiocompatibility techniques
Soft Skills
team managementcollaborationleadershipcontinuous improvementresource allocationpositive working culturecross-functional teamworkcommunicationtraining and developmentproblem-solving