Location
Pune | India
Job description
Job Title
Senior Toxicologist
Job Description
In this role, you have the opportunity to:
Generate Toxicological Risk Assessments for various respiratory medical devices based on the results of testing for compliance to ISO 10993 or ISO 18562. Collaborate with internal Biological Safety Engineers, Material Scientists, Regulatory, Quality, Design Engineering, and External Laboratory scientists to ensure that Philips Respironics medical devices are safe for use by their intended patient population.
You are responsible for:
- Preparation of toxicological risk assessment and dossiers (e.g., profiles) using Organization for Economic Co-operation and Development (OECD), European Chemicals Agency (ECHA) and Restriction of Chemicals (REACH) guidance and any other regulatory agencies databases.
- Gather information, provide guidance, answer Regulatory agency, and project team inquiries regarding all testing standards.
- Lead and/or manage the design, monitoring and interpretation of In Vitro, In Vivo, or pre-clinical bio-compatibility studies conducted under Good Laboratory Practices (GLP).
- Prepare expert reports on toxicology and patient risk in the support of regulatory documentation.
- Interpreting the results of E/L and VOC tests for impacts to patient safety.
- Documenting biological risk assessments and analyzing results from Contracted Resource Organizations (CRO's).
- Interacting with Regulatory Agencies to address test strategies and questions related to toxicological assessments.
- Communicate with Philips NPD teams and CROs to explain the results of toxicological assessments.
- Assist Philips' development teams in selecting proper materials for use in medical devices.
You are a part of:
Philips' is dynamic Healthcare Technology organization that designs and develops life-saving Respiratory Care products. At Philips, we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Our tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in Respiratory Care.
To succeed in this role, you should have the following skills and experience:
- Minimum of a BS in Toxicology or related fields, MS or PhD desired.
- Minimum of 7+ years' experience in Toxicological/Biological Risk Assessments
- Certification by the American Board of Toxicology (DABT) or other equivalent health science or medical professional certifications is desired.
- Knowledge of biological test methods for compliance to ISO 10993 (required) and ISO 18562 (desired).
- Experience conducting biological assessments and documenting biological test evidence to support regulatory agency submittals.
- Experience working with outside test labs to generate test plans and evaluate results for compliance to biological standards.
- Knowledge of FDA 2020 Guidance Document 'Use of International Standard ISO 10993-1'
- Strong commitment to quality and detail.
- Aptitude to understand regulations and compliance standards.
- Strong ability to work independently with minimal guidance.
- Ability to multi-task to support simultaneous projects.
- Ability to overcome obstacles and provide solutions to complex problems.
- Strong written and verbal communications skills.
Behaviors: The successful candidate will demonstrate the following:
- Leadership: The ability to make things happen by encouraging and channeling the contributions of others recognizing and addressing critical issues in a timely manner and acting as an agent for change and continual improvement when required to achieve results.
- Accountability/Ownership : Work closely with team members and take ownership - be a mentor to junior engineers
- Influence : The demonstrated ability to gain acceptance and commitment from others to one's own beliefs and ideas.
- Negotiating: The ability to construct and maintain a strong bargaining position to ensure positive response and agreement: striving for win-win situations.
- Adaptability: Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.
- Data-driven decision-making : ability to move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues.
- Relentless focus on Quality and Transparency as an organizational value.
You are a part of:
Philips' is dynamic Healthcare Technology organization that designs and develops life-saving Respiratory Care products. At Philips, we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Our tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in Respiratory Care.
How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
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