Technical Analyst

4 days ago

Bengaluru, India Celegence Full time

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 PowerPoint, 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

  • Informatica MDM Technical Specialist

    3 weeks ago

    Bengaluru, Karnataka, India SGS Technical Service Full time

    Job SummaryWe are seeking an experienced Informatica MDM Technical Specialist to join our team at SGS Technical Service.Key ResponsibilitiesWork closely with solution architects, business analysts, and product owners to understand the data & business process and work on development activities.Produce and develop detailed MDM design specifications, and...

  • Technical Requirements Analyst

    2 hours ago

    Bengaluru, Karnataka, India Growel Softech Pvt. Ltd. Full time

    Technical Requirements Analyst Job Description:Growel Softech Pvt. Ltd. is seeking an experienced Technical Requirements Analyst to join our team. The ideal candidate will have 5-7 years of experience in system analysis, integration, and troubleshooting, as well as expertise in APIs, Soap web services, and other integration services.Main Responsibilities:-...

  • Technical Systems Analyst

    3 days ago

    Bengaluru, Karnataka, India Growel Softech Pvt. Ltd. Full time

    About UsGrowel Softech Pvt. Ltd. is a leading technology firm dedicated to delivering innovative solutions.We're looking for a skilled Technical Systems Analyst to join our team!Job DescriptionAs a Technical Systems Analyst, you will be responsible for analyzing, designing, and implementing systems that meet business needs.You will work closely with...

  • Technical Business Analyst

    3 weeks ago

    Bengaluru, India PureSoftware Ltd Full time

    Hi, We need immediate joiners for Life asia as a technical business analyst. Exp- 10+ years Location - Bangalore

  • Technical Business Analyst

    3 weeks ago

    Bengaluru, India PureSoftware Ltd Full time

    Hi,We need immediate joiners for Life asia as a technical business analyst.Exp- 10+ yearsLocation - Bangalore

  • Technical Business Analyst

    3 weeks ago

    Bengaluru, India PureSoftware Ltd Full time

    Hi,We need immediate joiners for Life asia as a technical business analyst.Exp- 10+ yearsLocation - Bangalore

  • Technical Business Analyst

    1 month ago

    Bengaluru, India Luxoft Full time

    Project Description:We are looking for a Technical Business Analyst with experience in working on high-performing, scalable, enterprise-grade applications.You will be part of FX Enhancements team that works on critical Global Markets platforms with deliveries across front, middle and back-office functionalities on the vendor...

  • Technical Business Analyst

    1 month ago

    Bengaluru, India Luxoft Full time

    Project Description:We are looking for a Technical Business Analyst with experience in working on high-performing, scalable, enterprise-grade applications.You will be part of FX Enhancements team that works on critical Global Markets platforms with deliveries across front, middle and back-office functionalities on the vendor...

  • Technical Business Analyst

    1 month ago

    Bengaluru, India Luxoft Full time

    Project Description:We are looking for a Technical Business Analyst with experience in working on high-performing, scalable, enterprise-grade applications.You will be part of FX Enhancements team that works on critical Global Markets platforms with deliveries across front, middle and back-office functionalities on the vendor...

  • EHS Technical Analyst

    2 weeks ago

    Bengaluru, Karnataka, India 3M Technology Center of Excellence Full time

    The EHS IT Reporting Analyst will ideally have a mix of technical, analytical, and some project skills and experience. This is a client facing IT position for working on strategic, global reporting solutions for the 3M Environment, Health & Safety (EHS) & Product Stewardship (PS) Departments.The analyst will work on PS & EHS reporting projects, coordinating...

  • Key Technical Business Analyst

    3 weeks ago

    Bengaluru, Karnataka, India Luxoft Full time

    At Luxoft, we are seeking a highly skilled Key Technical Business Analyst - Enterprise Solutions to join our team in Bangalore. This is a unique opportunity to work on high-performing, scalable, enterprise-grade applications and contribute to the success of our Global Markets platforms.The successful candidate will be part of the FX Enhancements team,...

  • Technical Business Analyst

    2 weeks ago

    Bengaluru, Karnataka, India Luxoft Full time

    Job DescriptionAs a Technical Business Analyst for Luxoft's Treasury IT team, you will be responsible for delivering projects for the bank's treasury division. The role requires engagement with relevant business stakeholders and collaboration with the delivery team to ensure timely and quality delivery.The successful candidate will have excellent Business...

  • Technical Quality Analyst

    7 months ago

    Bengaluru, India BETSOL Full time

    Description As a Quality Analyst in Support Services team, the goal of the right candidate is to maintain a high and consistent level of support quality across all clients. The primary aim of this resource will be to ensure customers always get excellent treatment. Key Highlights of the Job: Review and Resolve Escalations If a service team...

  • Technical Configuration Analyst

    4 weeks ago

    Bengaluru, Karnataka, India Microland Full time

    Job Summary:We are seeking a highly skilled Technical Configuration Analyst to join our team at Microland. In this role, you will be responsible for analyzing configuration files in target switches, selecting target interfaces for modification, and producing lists of devices and interfaces to modify.Key Responsibilities:• Analyze configuration files in...

  • Cloud Platform Technical Business Analyst Position

    4 weeks ago

    Bengaluru, Karnataka, India Manhattan Associates Full time

    We are seeking a skilled Technical Business Analyst to join our innovative cloud platform team. As a key member of the team, you will bridge the gap between business needs and technical solutions.Job DescriptionIn this role, you will work closely with stakeholders to document solutions and present end results effectively. Your excellent communication and...

  • Master Data Management Developer

    2 months ago

    Bengaluru, Karnataka, India SGS Technical Service Full time

    Job Title: Master Data Management DeveloperAbout the Role:We seek a skilled Master Data Management Developer to join our team at SGS Technical Service. In this role, you will be responsible for designing and implementing Master Data Management (MDM) solutions using Informatica MDM.Key Responsibilities:Work closely with solution architects, business analysts,...

  • SAP Technical Analyst

    2 weeks ago

    Bengaluru, Karnataka, India Promaynaov Advisory Services Pvt Ltd Full time

    About the RoleWe are seeking an experienced SAP Technical Analyst to join our ERP team as an ERP Development Expert. In this role, you will have the opportunity to partner with key stakeholders, architects, and AMS providers to ensure timely delivery of secure and compliant technical solutions.

  • Technical Business Analyst for PeopleSoft Applications

    3 weeks ago

    Bengaluru, Karnataka, India Oracle Full time

    Job OverviewWe are seeking a seasoned Technical Business Analyst to join our team, focusing on delivering exceptional services for PeopleSoft FSCM, HCM, and Campus applications.About the RoleThis IC3-level position is responsible for diagnosing and resolving PeopleSoft-related issues, ensuring the accuracy of business systems. You will interact with business...

  • Senior Technical Analyst

    6 months ago

    Bengaluru, India Computacenter Full time

    ISMS - Security Analyst Life on the team A fantastic opportunity has arisen for a technical role to join Computacenter’s dynamic and rapidly expanding Digital Infrastructure group. Successful applicants will be joining a truly global organisation, delivering services into over 70 countries worldwide, with major offices across Europe, the Americas,...

  • Business Analyst Lead: Technical Support

    3 months ago

    Bengaluru, India Gallagher Full time

    Overview The Talent Acquisition Business Analyst Lead: Technical Support role is part of TA Global Support team’s (TAGS) operating model. This model is designed to support back-end aspects of the recruiting hiring workflow and processes efficiently. We are seeking a proactive and detail-oriented individual with a strong understanding of TA and passion for...