Technical analyst
4 days ago
About the Company: Celegence LLC is a privately owned business based in Chicago, IL with offices in the U. K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. Celegence vision is to be the premier niche provider of Regulatory Affairs services in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value. Education: Bachelor’s Degree/Post Graduation in any relevant Life Sciences field. Master’s Degree is preferred. Experience: Thorough understanding of Gap assessment of Technical file, Gap assessments for PMS, QMS, Harmonized standards. Hands on experience on Technical file, PMS, QMS, Harmonized standards document remediation. Preparing GSPR checklists Sound understanding DHF Remediation, Risk Remediation, Design Controls, Design Risk Management (DFMEA), Design Inputs & Outputs, Design Verification & Validation, and Product Requirements Minimum 3 years of experience in Medical Device Regulatory documentation Familiarity with the Life Sciences Industry, preferably Regulatory Services Experience in creating high quality deliverables for customers Experience in handling projects and engaging with multiple clients independently Experience of working on projects involving all devices classes from various Therapeutic Areas Skills: Technical Skills: Knowledge of Technical file remediation and related documents and regulatory requirements Understanding of Medical Devices Directive (MDD) 93/42/EEC, Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, (EU) 2017/745 (MDR), (EU) 2017/746 (IVDR) Proficiency with Microsoft Office (Word, Excel, and Outlook) Hands on experience on presentation tools such as Power Point, Visio etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage Effective reviewing skills for review of work done by trainees/junior writers Non-Technical Skills: Strong verbal and written communications skills Ability to work as part of a team A constant zeal towards learning and skill development Potential to multitask and work within timelines Ability to understand and deliver on customer requirements Mentoring skills to act as trainer/mentor for junior members of the team Competencies: Basic English grammar, punctuation, and sentence construction Logical comprehension Knowledge of medical terminology Excellent Communication (Writing and Verbal) Quality focused mindset Good time management Good stakeholder management Personal Traits: Positive Attitude Initiative and Commitment Detail Oriented Team player Focused and sincere Ownership and accountability of work Flexibility to work on other PMS documentation complying to MDR, and IVDR Roles & Responsibilities: Ensure on-time development and delivery of high-quality regulatory documents (Technical files, GSPRs, Gap Assessments, Risk management documentation, etc.,) compliant with MDR, and IVDR. Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation Assist the Team Lead/Manager in the development of schedules to ensure timely delivery Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables Train and mentor junior members of the team on technical/process related aspects Conduct proofreading, editing, document formatting, review comment incorporation and document completion / approval activities Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use Conduct editing, proofreading, document formatting, and other document completion/approval activities
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Business Analyst Lead: Technical Support
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