Biocompatibility Specialist Ii

Our search for better is changing the lives of our customers. It’s changing the careers of our people too -creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring as Biocompatibility Specialist, and you won’t either.

As a Biocompatibility Specialist you will work within prescribed ISO 10993 Standards and ensures specific compliance to all national and international regulations relevant to Biocompatibility. Function as a Subject Matter Expert (SME) in biocompatibility supporting Global Operations and Supply in evaluating established device, material, and process changes through the change control process either with Safety Assessments or updates to existing biological evaluations of existing products and associated processes. You will also support projects/programs in terms of biocompatibility of medical devices, materials, and processes.

**Key Responsibilities**:

- Manage and oversee the SME role for Biocompatibility for all change controls withing Convatec QMS.
- Investigate and evaluate risk to patients with unintended contamination or processes within a Safety Assessment.
- Develop or revise biological evaluation protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers.
- Understand biocompatibility strategies that are formed in consideration of product and process changes, gaps in materials, design and process to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety.
- Evaluate and execute biocompatibility studies, conducted by external laboratories, in support of programs dealing with our medical devices.
- Make positive contributions to, recommend approaches to, and support updating/ developing procedures for internal and external guidance document as they relate to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA)
- Support biological hazards risk analysis activities.
- Interface with and indirectly report to corporate biocompatibility team and represent biocompatibility on project/program teams.
- Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations.

**About you**:

- BS in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; advanced degree (MS or PhD) in these fields preferred.
- Fundamental understanding or direct experience of the ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology
- Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverable

**Language**s**
- English

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.

This is stepping up to a challenge.

This is work that’ll **move** you.

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**Equal opportunities**

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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