Danaher takes its name from a tributary of the South Fork Flathead River in western Montana. In the early 1980s, this was the setting for the fishing trip where Steven and Mitchell Rales envisioned a new kind of manufacturing company one dedicated to continuous improvement and customer satisfaction. The root “Dana” is an ancient Celtic word meaning “swift flowing,” an apt descriptor for the nimble mindset and rapid flow of innovation that have defined Danaher for decades.
Post : Quality and Regulatory Analyst
Job Description
Reporting directly to the QRA Team supervisor this position will be responsible for managing the day to day activities of Post market activities linked to all Life sciences BEC products in the portfolio (more than 200 products belonging to 3 classes). Collect and Analyze all the information on BEC products and Competitors on the market to perform proactive PMS report. Ensure compliance of global procedures and activities to (EU) 2017/746, 21 CFR 820, ISO 13485, ISO 9001, MDSAP, Beckman Coulter corporate Quality system requirements. The position location can be remote.
Essential Duties and Responsibilities
• Make literature search plan and document the references as per CPR (Clinical performance report)
• Writing scientific validity report (SVR)/state-of-the-art (SOTA)/clinical approaches for a device following global SOP
• Participate in post-market surveillance activities by leading routine systemic literature reviews (e.g. screen articles against inclusion/exclusion criteria, extract data from included studies, interpret study results, synthesize literature and prepare formal reports from the summaries)
• Maintain knowledge of current related internal and external standards, regulations and technologies (as example Flow cytometry)
• Search in regulatory database (as example MAUDE) for Post-market Clinical Surveillance data for In-vitro diagnostic devices and medical devices
• Make search strategies according to customer needs: PubMed, M-library, Cochrane databases using PICO method and assess the articles based on inclusion and exclusion criteria and summarize the results in respective reports
• Make a post-market surveillance plan and summarize the PMS findings in a PMS Report/PSUR in-vitro diagnostic devices
• With clear and factual communication, you will follow up on files, organize the necessary reviews with the various stakeholders (Engineering, R&D, Manufacturing, Quality Control, Marketing).
Candidate Profile
• Master’s degree in science, medical, clinical research associate with 8-10 years or or PhD with at least 5-7 years.
• Atleast 2 year of industrial experience on a similar position.
• Experience in flow cytometry is a “nice to have”. Candidate should have handled multi-parameter flow cytometry assays independently, including trouble shooting issues.
• Experience working with medical device quality systems in compliance with US FDA regulations (21 CFR), ISO 13485 and IVDR EU 2017/746, ISO 9001.
• In Vitro Diagnostics (IVD) experience including medical device development will be preferable
• Training or experience in the field of medical device development
• Training or experience in Good Clinical Practices (GCP)/ International Council for Harmonization (ICH) will be preferable
• Experience in leading continuous improvement efforts, in both quality systems and products.
Required Competencies
• Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams and regulators
• Ability to drive results, foster teamwork, handle pressure, and provide feedback
• Must be able to demonstrate skills in root cause investigation and problem solving
• Must have critical thinking skills and good judgment working in an independent environment.
• Organized and detail-oriented
• High level of initiative, self-motivation and energy.
• Reliable and responsive.
• Customer focused
• High level of integrity
• Goal oriented, interpersonal, self-motivated and team player
Additional Information
Experience : 5+ years
Qualification : Master’s degree in science, medical, clinical research associate
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality & Regulatory Affairs
End Date : 20th December 2023
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