Responsibilities and Accountabilities

• Be accountable for robust biocompatibility evaluation outcomes with technical leadership and sound strategies for successful regulatory submissions.
• Deliver biocompatibility assessments and biocompatibility evaluation plan and report complying with applicable biological evaluation standards and FDA guidance documents within a risk-based framework.
• Maintain a knowledge of applicable external standards and regulatory requirements for the biological safety of medical devices and mentor the development of these knowledge in others.
• Review biocompatibility test results to determine adequacy of data to meet requirements for the biological effects, and utilize problem solving skills and technical knowledge to troubleshoot unexpected results.
• Manage multiple projects requiring biocompatibility evaluation ensuring timely completion of required tasks to meet project schedules.
• Collaborate and clearly communicate with internal and external stakeholders (e.g. Contract Research Organizations (CROs)) to ensure appropriate planning and execution of risk assessments and required testing.
• Support regulatory submissions to global regulatory agencies to elaborate on the product biocompatibility strategy and data in response to additional information requests.
• Collaborate with Global Supplier Alliance (GSA), engineering teams, and external vendors to procure material specifications and safety data sheets in order to assess safety of products.
• Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of biological safety assessments and test plans/reports.
• Perform gap analysis of external standards, regulatory requirements and guidance associated with biological safety evaluation, and minimize the negative impact of such gaps on the products and business.
• Provide technical mentoring and training to the broader audience within the organization as required on process and product engineering.

Position Specific Skills and Challenges

• Extensive knowledge of FDA and ISO 10993 biological safety requirements and test methods including chemical characterization, and Good Laboratory and Good Manufacturing practices (GLP and GMP).
• Ability to interact at the highest professional manner with all organizational levels.
• Adaptation of business process to align with industry standards and best practices.
• Excellent written and verbal communication skills to effectively interact with and contribute constructively to a global team environment internally and externally.
• Good interpersonal skills and function successfully in a collaborative environment.
• Planning and organizational skills to prioritize and handle multiple tasks with a sense of appropriate urgency.
• Attention to detail necessary to maintain the required documentation.
• Developing technical prowess in self and others.
• Highly motivated self-starter; be proactive and creative in solving technical problems.
• Proficiency in Microsoft Office suite (e.g. Word, Excel, PowerPoint, Outlook, OneNote).
• Must be willing to travel.

Qualifications and Experience

• 7+ years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations and a Bachelor's degree with a discipline in Toxicology, Chemistry, Biochemistry, Biomedical Engineering, Bioengineering, or similar science/engineering discipline, or equivalent combination.
• A complete understanding and wide application of principle, theories, and concepts in biocompatibility per ISO 10993.
• Must have prior experience independently developing and driving biocompatibility evaluation strategies with scheduled and defined dependencies between tasks and deliverables for inclusion with worldwide regulatory submissions.
• Must have prior experience in supporting worldwide market registration.
• Proven experience with project management skills.