The Biocompatibility Specialist is responsible to ensure the evaluation of biological safety and performance of Merz medical devices. She/he is responsible for study design, planning, coordination and overseeing of her/his activities to support product development and lifecycle management in terms of biocompatibility and toxicology.
Essential Duties and Responsibilities
Design preclinical programs to evaluate and demonstrate the safety and performance of medical devices in accordance with ISO standards and regulatory requirements and internal quality procedures. Preparation of Biological Safety Evaluation Plan/Report and/or Biological Risk Assessments.
Coordinate and oversee biocompatibility activities with external partners such as CROs for biocompatibility testing, including subcontracting, planning, organization, monitoring and review of data quality of biocompatibility studies.
Representation as expert function (biological safety) in project teams: Management of biocompatibility activities as team member of Expert/MPC Teams for medical devices, including creation of preclinical work packages, ensuring data quality, timeline and budget delivery.
Support in delivering regulatory document (IDE, BSEP, BSER, IND, eCTD, IB, IMPD, toxicological assessment) to ensure achievement of market approval.
Review and/or update of regulatory documents to maintain the registration of medical devices following market approval.
Knowledge, Skills and Abilities
Expertise in biocompatibility for medical devices - Required
Familiar with biological safety evaluation standards (e.g., ISO 10993 series) - Required
Fluency in English (French or German is a plus) - Preferred
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
