Regulatory Affairs Quality Supervisor

Devesh Sanjay Kanekar

adwlox@r.postjobfree.com +1-857-***-**** www.linkedin.com/in/deveshkanekar Boston, MA EDUCATION:

Northeastern University, College of Professional Studies, Boston, USA Jan 2021 – Dec 2022 MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices Relevant Coursework: FDA Pharmaceutical and Medical Device Regulations, Pharmaceutical Engineering, Pharmaceutical and Medical Device Law, Introduction to Safety Sciences, Fundamentals of Clinical Trials: Human Experimentation, and Product Lifecycle Management

University of Mumbai, Mumbai, India July 2014 - May 2018 Bachelor of Pharmacy

WORK EXPERIENCE:

Aerosol Containment Co, LLC, Sudbury, Massachusetts Sept 2022 – Dec 2022 Regulatory Consultant

• Drafted a few sections of the 510(k) submission for class II medical device

• Participated in daily and weekly meetings to keep the project timelines on track and draw strategies for the FDA

• Consulted cross functional teams about a traditional 510(k) execution

• Assisted the software team in reviewing requirements in FDA guidance documents Breegi Scientific INC., Woburn, Massachusetts Apr 2022 – Sept 2022 Regulatory Consultant

• Participated as a team member in product lifecycle management projects by providing regulatory feedback and guidance throughout the product development cycle additionally monitored project status and deadlines

• Prepared General Safety and Performance requirements (GSPR) checklist data by Annex I of EU MDR for the device and processed documentation required for new product introductions and predicate products in European union market

• Ensured compliance to develop additional regulatory knowledge of worldwide guidelines, standards, and regulations based on business needs also supported UDI and GUDID database operations Indchemie Health Specialties Pvt. Ltd., Daman, India Feb 2019 – Nov 2020 Regulatory Affairs Officer

• Contributed to the preparation, compiling, and timely submission of regulatory deliverables in accordance with applicable regulations.

• Revised and audited SOPs and BRs responsible for quality management system

• Validated regulatory goals and deliverables, implementing procedures to ensure with worldwide regulations research

• Collaborated with the cross-functional team and stakeholders regarding potential regulatory issues ACG Associated Capsule Pvt. Ltd., Mumbai, India Jun 2018 – Jan 2019 Quality Supervisor

• Maintained company’s Change Controls, CAPAs and Deviations, Document Numbering, to support quality management system

• Monitored quality of the process by revising SOPs and BRs

• Worked with cross functional teams to improve quality of the process ACADEMIC PROJECTS: Northeastern University

• Advance Regulatory Writing – Medical Device Submission: Drafted mock letters to FDA regarding FDA 513(g) cover letter and Q-submissions. Also Designed regulatory strategy according to Health Canada for Medical Device Therapy lasers.

• Medical Device Development – PMA Submission: Planned mock regulatory strategy for Spatz3 medical device

(adjustable balloon system). Prepared for Pre-market approval application, pre-IDE meeting, and analyzed and planned post-marketing regulatory activities

SKILLS:

Technical: Microsoft Office, Adobe Acrobat, adwlox@r.postjobfree.com, eumdr.com Regulatory Affairs: IND (21 CFR 312), NDA (21 CFR 314), BLA (21 CFR 601.2), ANDA, eCTD, 510(k), 21 CFR 11, 21 CFR 50, IRB, ICH E6(R2), ISO 13485, 21 CFR 211 & 212, Technical Regulatory Writing

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