Arti Arvind, MS, RAC (US, EU)
Regulatory Affairs Manager at Philips
Regulatory Affairs Manager at Philips
- Regulatory leader with well-rounded experience in medical device/ IVD industries as well as in research/academia settings; holds a M.S. degree in Regulatory Affairs and a M.S. degree in Microbiology.
- RAC (US, EU) certified professional with hands-on experience in FDA 510(k) submissions and pre-submissions, IDE Supplements and 5-day notifications, IDE Annual Reports, EU MDD and MDR technical file preparation, Notified Body design dossier submissions, Health Canada Class II and III submissions, China type testing strategy and NMPA product registrations, Artificial Intelligence (AI) regulatory strategy for SaMDs.
- Experienced in leading MDSAP audits, interacting with FDA and Notified Bodies.  
- Experienced Professor adept at lecturing regulatory affairs courses in a Masters’ level program.
Philips
https://www.linkedin.com/company/philips
•	Lead and manage the Obstetrics - Fetal monitoring & Connected Sensing regulatory team by providing leadership on regulatory strategy and global registrations of NPIs, MDR compliance, and sustaining releases.  
•	Previously, Regulatory Program Manager responsible for EU MDR regulatory strategy and deployment resulting in successful delivery of MDR compliant products. Acted as regulatory lead during MDSAP audits and point person for interfacing with Notified Body.
Home-based, United States
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Regulatory Affairs Manager
Philips
https://www.linkedin.com/company/philips
•	Provide global regulatory strategy for registration of Philips Image Guided Therapy Systems (IGT-S) headquartered in Best, Netherlands
•	Act as chair of Standards Roadmap team and project manage assessment of new standards and changes to regulations
•	Oversee and approve various product development gates and phases for NPI/large scale projects and design changes during Program Management Team meetings.
•	Strategize and program manage EU MDR deployment for IGT-S Class IIb products
Best, North Brabant Province, Netherlands
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Senior Manager, Regulatory Affairs
Philips
https://www.linkedin.com/company/philips
• Provide regulatory support and strategy for NPI and sustaining projects for both standalone imaging software (SaMD) and hardware (capital equipment such as Ultrasound diagnostic systems and transducer, and Patient Monitoring systems and accessories)
• Regulatory SME for the Artificial Intelligence regulatory strategy for Ultrasound systems; SME for state of the art standards compliance.
• Prepare and submit traditional 510(k)’s to FDA, Health Canada Class II and III submissions, provide China type testing strategy and NMPA product registrations, maintain EU technical files, DoC’s and CERs, support registrations in other major key markets such as Brazil, Singapore, Korea, Japan, Russia and Malaysia.
• Provide regulatory support for MDSAP, FDA and Notified Body audits.
• Regulatory SME for the EU MDR gap analysis evaluation; provide strategy in addressing gaps in clinical evaluation and other new requirements in the MDR.
• LEAN certified and knowledgeable in Lean methodologies and deployment.
Andover, Massachusetts, United States
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Senior Regulatory Affairs Specialist
Northeastern University
https://www.linkedin.com/company/northeastern-university
•	Provide lectures for regulatory affairs courses and mentor students enrolled in the Masters of Regulatory Affairs program.
•	Developed the curriculum from scratch for RGA6002 Regulatory Compliance and Practice and was the first Professor to teach the course in the Masters program.
Boston, MA
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Lecturer - MS in Regulatory Affairs for Drugs, Biologics and Medical Devices
Abbott
https://www.linkedin.com/company/abbott-
•	Regulatory SME for cross-functional core teams for Optical Coherence Tomography (OCT) Imaging Systems, imaging catheters and the Thoratec Percutaneous Heart Pump system (PHP - LVAD device).
•	Supported IDE submission for PHP; reviewed clinical study protocols, PMS reports, and submitted IDE supplements, IDE annual reports to FDA.
•	Prepared 510(k) submissions for FDA, Health Canada Class III product submissions and supported other key market submissions. 
•	Prepared Design Dossier and supplements submissions, Change Notification Forms to Notified Body for EU Class III imaging catheter changes.
Westford, MA
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Regulatory Affairs Specialist II
Siemens Healthcare Diagnostics
https://www.linkedin.com/company/siemens-healthineers
•	Provided regulatory support and representation for in-vitro diagnostic (IVD) new product development and design change projects. 
•	Prepared pre-IDE and 510(k) submissions to FDA, prepared strategy and meeting materials for Pre-Submission meetings as well as Submission Issue meetings, and represented Regulatory Affairs during in-person meetings with FDA.
•	Interfaced with a key team of OEM manufacturers located OUS to strategize submission requirements to FDA including acceptable performance criteria in comparison to the predicate, as well as requirements for EU and US clinical trials.   
•	Prepared submissions for European regulatory approvals (CE mark applications, EU Technical Files, DOCs etc.), global dossiers and supported Health Canada submissions.
•	Regulatory SME for the core team involved in complying with the FDA UDI final rule. 
•	Prepared annual laser reports and Certificate to Foreign Government applications to FDA, and maintained establishment registration and device listing for all products.
Norwood, MA
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Regulatory Affairs Specialist II
Unilever
https://www.linkedin.com/company/unilever
•	Independently developed a conceptual and dynamic mathematical model to quantify the recontamination risk in ice cream products. Conducted statistical analysis and suggested risk management options to reduce the identified risk. 
•	Tested and identified possible biological indicator groups of microorganisms that might occur with Listeria species in sampled biofilms.
•	Conducted environmental monitoring procedures at Unilever ice cream factories and tested product conformance to manufacturing standards.
•	Conducted an in-depth literature review of various recontamination scenarios that might occur during the manufacture of ice cream products. Generated input parameters for the mathematical model and validated the same.
Vlaardingen Area, Netherlands
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Research Associate, Microbiology group
Wageningen University and Research centre
https://www.linkedin.com/company/wageningenuniversity
•	Using bio-analytical techniques, identified biomarkers that could serve as predictive cellular indicators for the stress adaptive behavior of the pathogen Bacillus cereus. 
•	Performed extensive laboratory experiments using traditional techniques such as microbial culturing, plating and streaking as well as molecular biological techniques. 
•	Co-authored a paper on the research work which has been published in Plos One journal entitled, “Short- and Long-Term Biomarkers for Bacterial Robustness: A Framework for Quantifying Correlations between Cellular Indicators and Adaptive Behavior” (October, 2010).
Wageningen, The Netherlands
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Research Associate, Laboratory of Food Microbiology in association with TIFN
Master of Science (MS)
Recipient of the Regulatory Affairs scholarship award in 2013 
Courses: 
Drug and device regulations, Human experimentation, Regulatory overview of New Drug development, Regulatory overview of Medical device development, Regulatory overview of Biologics development, Clinical trial design and data analysis, Advanced writing in International biomedical topics, Canadian and Australian medical device regulations, International regulations - Canadian, Asian and Latin American Regulatory Affairs, Advertising and Promotion of drugs and devices, FDA law.
Regulatory Affairs in Drugs, Biologics and Medical devices
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Northeastern University
https://www.linkedin.com/school/northeastern-university/
MSc
Graduated with distinction (cum laude) from the MSc study.
Won the Wageningen University Fund (WUF-KLV) Best Dissertation Award for the MSc study
Food Safety (Specialization: Microbiology)
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Wageningen University
https://www.linkedin.com/school/wageningenuniversity/
Bachelor of Science - BSc
Nutrition & Dietetics
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University of Madras
https://www.linkedin.com/school/university-of-madras/
American Society for Quality (ASQ)
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Regulatory Affairs Professional Society (RAPS)
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Short- and Long-Term Biomarkers for Bacterial Robustness: A Framework for Quantifying Correlations between Cellular Indicators and Adaptive Behavior
Plos One
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0013746#aff1
Dean's scholarship award for academic excellence
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International Regulatory Affairs student scholarship
Received the best thesis award for the year from Wageningen University
WUF-KLV
Wageningen University Foundation WUF-KLV thesis award
Graduated with honors from the MSc study
Wageningen University and Research centre
Cum laude
Food Law
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Food Quality Management (QA-systems)
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Food Related Allergies and Intolerances
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Food Safety Economics
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Food safety management (Risk management)
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Immunology
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Microbiological and Toxicological Risk Assessment of foods
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Microbiology
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Toxicology
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Regulatory Affairs Professionals Society (RAPS)
bcert.me
Regulatory Affairs Certification (RAC) -  EU
http://bcert.me/snxzvblna
Regulatory Affairs Professionals Society (RAPS)
bcert.me
Regulatory Affairs Certification (RAC) - US
http://bcert.me/swcploasz
Regulatory Affairs Professionals Society (RAPS)
bcert.me
RAPS Member
https://bcert.me/sxrqzudqt
https://www.linkedin.com/in/ajkthakkar
Quincy, MA
Aj Thakkar
Senior Regulatory Affairs Specialist at Medtronic - Cardiac Surgery
https://www.linkedin.com/in/hardiyaneha
Greater Seattle Area
Neha Hardiya, MS, RAC Device
Regulatory Affairs Specialist
https://www.linkedin.com/in/divya-palan-9540
Greater Boston
Divya Palan, MS-RA, RAC
Senior Regulatory Affairs Specialist at Medtronic
https://www.linkedin.com/in/ravalkarishma
Boston, MA
Karishma Raval
Senior Regulatory Affairs Specialist at Smith & Nephew
https://www.linkedin.com/in/dalerafferty
Largo, FL
Dale Rafferty
Principal Specialist Regulatory Affairs -International
https://www.linkedin.com/in/shrenikdesai
Boston, MA
Shrenik Desai
Regulatory Affairs
https://www.linkedin.com/in/raps-admin-account-07354529
Rockville, MD
RAPS Admin Account
Regulatory at Regulatory Affairs Professionals Society (RAPS)
https://www.linkedin.com/in/thuy-nguyen-59a3565
Bothell, WA
Thuy Nguyen
Head of Quality & Regulatory Affairs, Ultrasound at Philips
https://www.linkedin.com/in/stephanieloots
Broomfield, CO
Stephanie Loots
Regulatory Affairs Professional
https://www.linkedin.com/in/jennifer-rae-51a42826
North Haven, CT
Jennifer Rae
Medical Devices - Sr. Director, Regulatory Affairs at Medtronic, Surgical Instruments
https://www.linkedin.com/in/kimtrautman
Reston, VA
Kim Trautman
Medical Device, IVD, and Combination Product Regulatory & Quality Expert
https://in.linkedin.com/in/sudhakar-mairpadi-094b6517
Gurgaon
Sudhakar Mairpadi
Director-  Regulatory and Govt Affairs ( Health care, Personal health) India and Indian subcontinent
https://www.linkedin.com/in/megan-elliott-287075a2
Broomfield, CO
Megan Elliott
Sr. Regulatory Affairs Specialist at Covidien (Medtronic Minimally Invasive Therapies Group)
https://www.linkedin.com/in/margishpatel
New York City Metropolitan Area
Margish Patel, MS, RAC
Sr. Manager, Global Regulatory Affairs-Biologics
https://www.linkedin.com/in/michellehuettner
Memphis Metropolitan Area
Michelle Huettner, RAC
Director, Regulatory Affairs, Orthopedics at Smith & Nephew
https://www.linkedin.com/in/masoomarazvi
Greater Chicago Area
Masooma Razvi, PharmD, RAC
Senior Manager Regulatory Affairs at Pfizer
https://www.linkedin.com/in/rabdulrahoof
Los Angeles, CA
Ruqayyah A.
Founder @CareerSavage | Regulatory Affairs Professional | Public Health Advocate | Career Coach | #1 Best Selling New Release Author📚
https://www.linkedin.com/in/nivedita-namjoshi
Boston, MA
Nivedita Namjoshi
Principal Regulatory Affairs Specialist at Cardinal Health
https://www.linkedin.com/in/pankti-shah-ms-mba-marketing-be-biomedical-7a9a6651
Warsaw, IN
Pankti Shah  MS, MBA (Marketing) , BE (Biomedical)
Senior Regulatory Affairs Specialist at Zimmer Biomet
https://www.linkedin.com/in/ajohnsonresearch
Cambridge, MA
Angela Johnson, PhD, PMP, RAC, CPGP
Expert in Developing Products, Businesses, and People in Life Sciences | Biotech, Medtech, & Health Tech
LinkedIn User
      
          



            
              
        
              
  

    
        I have worked with Aarathi for several years in her role as a Senior Regulatory Affairs Specialist. She has been instrumental in creating Regulatory strategies for some of the most cutting edge technology, including artificial intelligence. She brings a unique perspective to her strategies for business, allowing for Regulatory to work with the business to bring compliant products to market in a fast manner.  Amy Goldberg
      
          



            
              
        
              
  

    
        I had the pleasure to work with Aarathi at Siemens for 1.5 years.  She joined the Regulatory team as an intern, but quickly excelled to a Specialist II position.  I was particularly impressed with Aarathi's attention to detail and her ability to learn about our products and processes under a short period of time.  She was successful with managing multiple, competing high-priority projects.  Aarathi's hard-working, conscientious worth ethic along with her positive energy made her invaluable to the regulatory team.  Aarathi would be an asset to any team and she earns my highest recommendation. 
Liked by Arti Arvind, MS, RAC (US, EU)
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When an employee’s performance is consistently good, it becomes expected and may unknowingly be taken for granted. I have seen people in leadership…
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I have  the honor of joining the 20th annual MIT Sloan Healthcare and BioInnovations Conference (SHBC) on April 1st at the MIT. We will be…
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The pandemic has devastated the careers of millions of women in the U.S., and the share of women hired into leadership positions stalled in 2020…
Regulatory Affairs Alumni Network - College of Professional Studies
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Global Regulatory Affairs/Market Access Convergence
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Quality & Regulatory Network
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Boston Women In Biotech
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FOOD SAFETY AND QUALITY ASSURANCE
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Regulatory Affairs Professionals Society (RAPS)
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TiFN
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Alumni @Wageningen University & Research
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Pharmaceutical, Biotech, Medical & Healthcare Network: Business, Jobs, Events & News
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NEURAN (Northeastern University Regulatory Affairs Network)
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Clinical Research Network - News, Jobs & Events - Pharma, Healthcare, Medical Trials & Recruitment
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Bioscience Job Network
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Wageningen University & Research
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REGULATORY UPDATES
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