Vacancy caducado!
Description:
Provides expertise in biocompatibility of medical device materials through knowledge of and experience with biological evaluations in accordance with ISO 10993 and global regulatory filings.
Plans coordinates and leads activities in support of the development and improvement of medical devices used in various therapies that are associated with cardio-vascular surgical procedures.
Performs independent research and development activities towards the demonstration of biocompatibility of products using broad judgement to determine the methods and techniques required.
Determines biocompatibility testing regimen based on type of patient contact and duration of use.
Identifies master devices to be evaluated to represent multiple devices that share design characteristics and use conditions.
Collaborates with third party services/test laboratories to obtain quotes and schedule testing.
Obtain purchase orders and secure required test devices.
Provides expertise to support extractables and leachables testing of products relevant to use conditions.
Authors biocompatibility plans and reports complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework.
Reviews protocols reports toxicological risk assessments and regulatory submission summaries in collaboration with cross-functional team members and test laboratories.
Analyzes biocompatibility test results to determine adequacy of data to meet requirements for the biological effects.
Utilizes problem solving skills and technical knowledge to troubleshoot unexpected results and make scientifically-based decisions on whether additional testing is warranted.
Assists with regulatory submissions to global regulatory agencies to elaborate on the biocompatibility strategy and data in response to any additional information requests.
Collaborates with other scientists on material selection based on chemical and biological properties that comply with Materials of Concern MOC regulations globally.
Coordinates product stewardship activities through MOC identification in products using a priori knowledge supplier safety data sheets supplier declarations and lab testing.
Conducts MOC evaluations for compliance with regulations.
Collaborates with other subject matter experts to author justifications for the continued use of substances of concern based on solid scientific rationale and benefit-risk assessments.
Maintains compliance to global MOC regulations of released products through material and supplier changes. Identifies and closes MOC compliance gaps working with vendors and testing labs.
May contribute to scientific literature and conferences and participate in development of patent applications.
Qualifications:
Bachelor's degree in a scientific discipline and 4 years of relevant experience OR Master's degree with 2 years of relevant experience
Established knowledge of analytical chemistry techniques with application in pharmaceutical and/or medical device industry
Experience performing laboratory data interpretation including working with mathematical concepts relevant to the laboratory setting
Experience reading analyzing and interpreting common scientific and technical journals scientific procedures and regulatory guidelines.
Experience with performing statistical analysis of data
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
Vacancy caducado!