Senior Manager Biocompatibility

ConvaTec Group

Fully remote with occasional in-office presence as driven by business requirements.
10+ years biocompatibility experience
Iso 10993 standards expertise
Fda submission management
ConvaTec Group is seeking a Senior Manager of Biocompatibility to lead a team in delivering biological evaluations aligned with ISO 10993 standards. The ideal candidate will have over 10 years of experience in biocompatibility assessments within the medical device sector, and the role emphasizes collaboration, coaching, and compliance with global regulatory standards

Job Summary

  • The Senior Manager leads a team of specialists in delivering biological evaluations aligned with ISO 10993 standards for Convatec's four key product categories.
  • This role requires extensive experience managing complex FDA submissions and addressing regulatory queries while supporting new product development and lifecycle management projects.
  • The position involves coaching a team of six direct reports to maintain up-to-date knowledge of global medical device standards and foster a collaborative work environment.

Matching Summary

Match Score: 85

ConvaTec Group is seeking a Senior Manager of Biocompatibility to lead a team in delivering biological evaluations aligned with ISO 10993 standards. The ideal candidate will have over 10 years of experience in biocompatibility assessments within the medical device sector, and the role emphasizes collaboration, coaching, and compliance with global regulatory standards.

Skills & Requirements

Must-have

  • 10+ years biocompatibility experience
  • ISO 10993 standards expertise
  • FDA submission management
  • Biological evaluation execution
  • Team leadership and development

Nice-to-have

  • Cross-functional collaboration skills
  • Continuous process improvement mindset
  • Global regulatory knowledge
  • Positive working culture fostering

Key Requirements

  • BSc or higher in Biomedical Engineering, Biology, Biochemistry, Microbiology, or Toxicology
  • Advanced degree (MS or PhD) preferred
  • 10+ years industrial experience in Medical Device, Pharmaceutical, or Biotechnology
  • Proven track record with complex FDA submissions

Work Rights

Not specified

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