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About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant 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