Job Summary and Primary Responsibilities
We are seeking an experienced and responsible Senior Biocompatibility Associate who will make an important contribution to patient safety by supporting our innovation platforms in terms of biocompatibility of medical devices, materials, and processes. The person will be a part of the NuVasive R&D team and will work closely with program/project cross-functional teams to provide biocompatibility deliverables of legacy and new products to meet compliance with global regulatory requirements and standards. The role requires knowledge of medical device designs, materials/manufacturing process and overall biological evaluation throughout the product lifecycle. Candidate must have strong ability to interpret biocompatibility regulatory requirements and guidance and help define the strategy to meet regulatory requirements as appropriate for new product/system development and product/system change activities. Candidate must have strong ability to critically review detailed scientific information, organize existing data into required documentation, assess any gaps, and help with testing strategies.
- Collaborate with biocompatibility team members and assist with regulatory submissions to global regulatory agencies and elaborate on the biocompatibility strategy and data in response to additional information requests.
- Understand biocompatibility strategies that are formed in consideration of gaps in materials, design and manufacturing process to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety
- Analyze, interpret, and draw conclusions from device material information and biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations
- Gather and organize data from engineering drawings of devices and related material standards/specifications/certifications to identify and characterize device materials
- Support biological hazard risk analysis activities and create technically sound documents, protocols, and reports to support biological evaluations
- Liaise with internal resources (development, regulatory, quality, clinical and manufacturing) and external resources (e.g. Contract Research Organizations (CROs)) to develop and coordinate test strategies and ensure appropriate execution of required testing in compliance with internal SOPs, recognized standards, and applicable global regulatory requirements (e. g. FDA, ISO, MHLW, and NMPA)
- Interface with key business partners and represent biocompatibility team on project/program teams
Required Skills / Capabilities
- Fundamental understanding or direct experience of the ISO 10993, ISO 19227 standards, toxicological assessment, extractable and leachable analysis and biocompatibility assessment methodology
- Knowledge and understanding of materials/properties (metals, polymers, etc.), chemical formulations, medical device manufacturing processes and contaminants.
- Knowledge of PROP 65, REACH and ROHS is desired but not required.
- Must possess strong analytical and process skills, and be computer proficient in MS Excel, MS Project, PowerPoint, Word, etc.
- Must be team oriented, with the ability to work well with diverse cross-functional teams and to interact at the highest professional manner with all organizational levels in an exciting and changing environment
- Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverable. Proven experience with managing priorities and time management is required
- Excellent communication skills, both verbal and written, and interpersonal skills to effectively interact with and contribute constructively to a global team environment, outside departments and externally - Strong organizational, prioritization and interpersonal skills. Evidence of accurate analysis of data.
- Knowledge of FDA and EU regulatory requirements within medical device industry
- Knowledge of cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the cleaning, sterilization, bioburden, bacterial endotoxin, and biocompatibility assessment of orthopedic implants and surgical instruments.
Education and Experience
- BS or MS in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Chemistry, Materials Science, Toxicology or equivalent area.
- 2-4 years industrial experience in the field of Medical Device with expertise in biocompatibility, toxicology, cleaning validation and/or special process validation
For roles that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The "EEO is the Law" poster options are available here . NuVasive's EEO policy is available here .
About NuVasive NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company's less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company's comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com .