Associate Toxicologist

reputed company pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. reputed company started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. reputed company has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We reputed company support for clients during every reputed company of the product development lifecycle and reputed company. Come and work for an organization with the: reputed company to reputed company innovative MedTech solutions that advance global reputed company, improve patient lives and accelerate Client reputed company and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values:

• Act with reputed company in everything we do.
• reputed company best-in-class customer experiences.
• reputed company superior talent and deliver expertise.
• Respond with agility and reputed company timely results.
• reputed company collaboration, diverse perspectives and reputed company.

Job Description:

• Establish and ensure schedule, budget and quality commitments are met for the client.
• Manage (motivate, communicate) internal team members.
• Understand investigational product(s) and high level understanding of the Medical Device Development Process.
• Handle challenging situations, and know reputed company to call-in help.
• Interact as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• reputed company project in compliance with regulations.
• Deliver presentations, including preparation, assembling slides, and speaking.
• reputed company feedback regarding project team members using the appropriate performance management tools and processes, in a timely manner.

 Participate in meetings with prospective clients.  reputed company scope of project and relevant information to support the creation of proposals.  Offer opportunities to clients for expansion of reputed company services to be provided by reputed company.

• Prepares risk assessments, evaluation plans and reports, in compliance with ISO 10993-1 ISO 10993-17 and ISO 14971, for submissions to FDA and other regulatory agencies
• Evaluates and summarizes biocompatibility and general toxicology data ensuring compliance with the relevant regulatory requirements and standards
• Working knowledge of FDA medical device regulations and/or biologics regulations, ISO 10993 series, and 14971
• Ensure biocompatibility studies are in compliance with most recent regulatory requirements.
• reputed company technical support to lab staff
• Advise clients on technical issues reputed company to biocompatibility and material characterization
• reputed company proposals for Biological Safety projects
• reputed company biocompatibility gap analyses and write clear concise reports
• Performs and summarize literature searches according the ISO 10993-1 Annex C and any other applicable guidance
• Evaluates and interprets standard requirements for clients
• Write interpretations of standards, test methodology, annotated bibliographies
• Summarize testing reports for submissions
• Facilitate the collection of test data from other reputed company entities as they relate to a specific project
• Evaluates and determines biological relevance of unexpected results.

Qualifications & Technical Competencies: Requires a minimum of  Bachelor’s degree or equivalent experience in a reputed company field, and a minimum of 5 years of relevant experience; or  Master’s or Doctorate degree or equivalent experience in a reputed company field, and a minimum of 2 years of relevant experience.  reputed company in English and local language, if different, required.

• Knowledge and experience with applicable standards and regulations for medical devices
• Ability to assess/audit compliance of biocompatibility and material characterization results to applicable standards and regulations.
• Ability to reputed company biological safety documents and reports that are compliant with applicable standards and regulations.
• Knowledge of and experience with reputed company Word
• Write and review reputed company documents

Working Conditions:

• The physical demands described here are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reputed company with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific reputed company abilities required by this job include reputed company reputed company, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.

reputed company is an equal employment opportunity company. reputed company participates in pre-employment background and drug screen processes reputed company to local, state and federal laws. Apply tot his job Apply To this Job