Lead Scientist, Biocompatibility Assessment

2 weeks ago


GondrecourtleChâteau, Grand Est, United States Abbott Laboratories company Full time

Position Overview:

As a Lead Scientist specializing in Biocompatibility, you will play a pivotal role in advancing Abbott's commitment to healthcare innovation. This position is integral to our mission of ensuring the safety and efficacy of our medical devices.

About Abbott:

Abbott is a global leader in healthcare, dedicated to helping individuals live healthier lives through our diverse portfolio of life-enhancing technologies. Our team of over 114,000 professionals serves communities in more than 160 countries.

Key Responsibilities:

  • Conduct comprehensive biocompatibility assessments and develop evaluation plans that adhere to established biological evaluation standards and regulatory guidelines.
  • Collaborate with cross-functional teams to support various projects, ensuring timely execution of biocompatibility evaluations.
  • Engage with diverse functional groups, including Research & Development, Regulatory Affairs, and Quality Assurance, to facilitate effective communication and project success.
  • Analyze biocompatibility test outcomes to validate data adequacy for biological safety, employing problem-solving skills to address any discrepancies.
  • Assist in the preparation of regulatory submissions, articulating biocompatibility strategies and addressing inquiries from global regulatory bodies.
  • Participate in design and risk assessment meetings to address biological safety concerns and maintain accurate records of assessments and reports.
  • Stay informed on external standards and industry requirements related to the biological safety of medical devices.
  • Conduct gap analyses of regulatory requirements and external standards to mitigate potential impacts on product safety and compliance.
  • Contribute to the development and implementation of comprehensive biocompatibility strategies.

Qualifications:

To be successful in this role, candidates should possess:

  • A Bachelor's degree in a relevant scientific discipline such as biology, biochemistry, or toxicology.
  • A minimum of 15 years of experience in a regulated environment, focusing on biological safety evaluations for medical devices.
  • In-depth knowledge of ISO 10993 principles and experience with biomaterials and toxicological assessments.
  • Familiarity with global regulatory frameworks, including EU and US medical device regulations.
  • Strong analytical and communication skills, both written and verbal.

Preferred Qualifications:

Advanced degrees (Masters or PhD) in relevant fields are highly regarded, particularly those specializing in medical devices.

Join Abbott and be part of a team that values innovation, diversity, and the pursuit of excellence in healthcare.



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