Rupa Sonawane
Stevenson Ranch,USA
Summary
Accomplished professional specializing in regulatory compliance and quality monitoring. Drives operational readiness and efficiency through comprehensive audit support, targeted training development, and collaboration with cross-functional teams, enhancing compliance accuracy and fostering a culture of continuous improvement.
Overview
18
18
years of professional experience
Work History
Sr MDR/Vigilance Specialist
MiniMed
Northridge, USA
07.2022 - Current
- Supported internal and external audits, providing front-room and back-room audit support and serving as a subject matter expert for quality, compliance, procedures, and documentation-related inquiries.
- Served as training subject matter expert, created and updated training materials to ensure accuracy and alignment with current procedures, controlled documents, and process changes.
- Functioned as the key subject matter expert for the Separation Project, delivered subject matter expertise, procedural guidance, and cross-functional coordination to facilitate project implementation and operational readiness.
- Oversaw inspection readiness tasks, ensuring regulatory evaluations and audits met compliance standards.
- Acted as primary CMT representative, facilitating workshops and leading continuous improvement initiatives to enhance processes.
- Acted as the CMT subject matter expert for trending meetings, provided insights into trends, identified potential improvement opportunities, and facilitated data-driven quality discussions.
- Presented CMT metrics during monthly Quality Reviews, communicating key information to stakeholders and leadership.
- Partnered with cross-functional teams on continuous improvement projects and system changes, driving implementation activities for improved compliance.
Post Market Surveillance Analyst II
Abbott
Sylmar, USA
03.2017 - 06.2022
- Established regulatory reportability decisions through comprehensive event investigations and application of regulatory decision models, enhancing overall compliance accuracy.
- Reviewed complaint communications to ensure regulatory compliance and assess reportability, emphasizing impacts on patient safety and business operations.
- Prepared regulatory reports for adverse events and/or malfunctions and ensured timely submission to the appropriate regulatory authorities.
- Evaluated identified complaints using clinical knowledge. Gathered data from clinical staff, field representatives, internal employees, and laboratory analysis to investigate complaints.
- Worked with cross-functional teams to ensure accuracy within the complaint and process.
- Conducted training sessions on medical device reporting for new hires, ensuring compliance with regulatory standards and mentoring peers through review process.
- Supported FDA audits by preparing detailed records and responses for incoming requests, facilitating efficient audit outcomes.
Medical Transcriptionist
IMS Health
Mumbai, India
01.2012 - 12.2016
- Transcribed medical dictations accurately using advanced transcription software.
- Reviewed and edited transcripts for accuracy in grammar, punctuation, and medical terminology to ensure high-quality documentation.
- Collaborated with healthcare professionals to clarify unclear dictations, enhancing overall transcription accuracy and reliability.
- Transcribed qualitative doctor interviews and focus group discussions for healthcare market research projects, providing valuable insights for major pharmaceutical companies like Sanofi, Lilly, and AstraZeneca.
Medical Science Liaison
Uth Healthcare
Pune, India
01.2011 - 12.2012
- Developed relationships with top KOLs and coordinated annual KOL summits, enhancing KOL mindshare through structured campaigns.
- Produced high-quality scientific and clinically oriented brochures, pamphlets, guides, promotional flyers, web content, and white papers for healthcare professionals.
- Led all phases of new drug product development from concept based on consumer insights through product development to regional/national launches and data analysis.
- Conducted product training for the sales representatives: new and old. Increased sales productivity by 20% and reduced new employee onboarding time by 15%.
- Conducted quarterly sales meetings for strategy, product launch and briefings - Established a new process for such meetings, focusing on ʻspeed to marketʼ and enhancing productivity.
Market Research Analyst
IMS Health
Mumbai, India
01.2009 - 12.2010
- Conducted primary and secondary market research for major pharma and nutritional companies like Lilly, Sanofi, Medtronic, and Pfizer, utilizing qualitative and quantitative surveys to provide strategic recommendations for future growth of top-selling brands.
- Executed customer needs assessments, designing market research, managing vendor selection, and presenting key deliverables and reports to inform recommendations and conclusions.
- Converted complex analysis results into clear Excel and PowerPoint presentations, enhancing client engagement through 7 lead presentations and support in 15 presentations to top executives in the pharmaceutical industry.
- Delivered high-quality projects aligned with client needs, providing tailored insights and actionable recommendations to enhance customer satisfaction.
Education
MBA - Healthcare
Symbiosis Institute of Health Sciences
Pune, India01-2009
M.B.B.S - Bachelor of Medicine & Surgery
Govt Medical College
Nagpur, India01-2003
Skills
- Regulatory compliance
- Regulatory reporting
- Complaint processing and investigation
- Quality Monitoring
- Process improvement
- Cross-functional collaboration
- Training
Timeline
Sr MDR/Vigilance Specialist
MiniMed
07.2022 - Current
Post Market Surveillance Analyst II
Abbott
03.2017 - 06.2022
Medical Transcriptionist
IMS Health
01.2012 - 12.2016
Medical Science Liaison
Uth Healthcare
01.2011 - 12.2012
Market Research Analyst
IMS Health
01.2009 - 12.2010
MBA - Healthcare
Symbiosis Institute of Health Sciences
M.B.B.S - Bachelor of Medicine & Surgery
Govt Medical College