Contracted opportunity through the end of 2020
Can this contract extend into 2021?
- Yes, there is a chance! Could also lead into permanent placement!
What are the top three to five technical skills wants for this role?
1. Understanding of ISO 10993-18 requirements.
2. Scientific analytical chemistry
3. Ability to write protocols and interact with 3rd party suppliers
4. Organizational skills and technical project management skills.
5. Ability to evaluate data and form conclusions and make assessments on if the data support compliance with the requirements.
What are the top three to five soft skills you would like to see for this role?
1. Define requirements when there is ambiguity
2. Communication (oral and written)
3. Critical thinking.
Any specific education or certifications needed?
- Chemistry knowledge/background
What is the expected interview process?
1. Phone Screening interviews
2. Possible second interview with additional team members
This position will support chemical characterization of medical devices through sample management, data management, verification and document generation extractables studies, assessments, and generation of materials for submission to meet the regulatory compliance timing for EU-MDR.
Essential Duties and Responsibilities:
- Manage activities for medical device compliance to new regulatory standards using an understanding of state-of-the-art chemical characterization (10993:18) requirements.
- Write extractables and leachables assessments and rationales for medical devices.
- Write protocols reports, procedures, gap assessments, and data summaries.
- Manage sample and testing scheduling associated with EU-MDR project milestones
- Evaluate analytical results, identify trends and exceptions.
- Perform calculations required for E&L testing (e.g., unit conversions)
- Data management (transcription and verification).
- Routinely consult and assist team members regarding problems and project work .
- Evaluate results relative to product requirements, definitions and/or project goals.
- Maintain knowledge of relevant QSR and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
- In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, is able to provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
- Attention to detail
- Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts
- Experience with extractables and leachables testing and Elemental Impurities
- Experience with techniques including GC/MS; LC/MS and ICP-MS
- Relevant technical writing and computer skills
- Flexibility and can shift gears comfortably
- Ability to objectively assess, organize, and clearly communicate complex information
- Interpret available information and make recommendations to resolve technical challenges
- Appropriately prioritize assignments to meet project schedules
- Good knowledge of word processing, spreadsheets, table and graph generation and use of applicable computer software
- Working knowledge of industry regulations
Experis is a global leader in professional resourcing and project-based workforce solutions. We deliver in-demand talent for mission-critical positions, enhancing the competitiveness of the organizations and people we serve. Our goal is to maintain a positive candidate and client experience through fitting the best candidates with the best positions.