Open to opportunities

Harsh Patel

@harshpatel13

I help medical device teams achieve compliant, market-ready registrations through regulatory and quality documentation expertise.

India

Message

What I'm looking for

I want to work on end-to-end medical device regulatory and quality compliance—preparing technical and quality documentation, resolving regulatory queries, and supporting inspections—while coordinating cross-functional teams to deliver timely, audit-ready outcomes.

I work as a Regulatory Affairs Consultant specializing in medical devices, supporting end-to-end regulatory and quality compliance for the Indian market. I prepare, review, and maintain regulatory documentation such as Device Master Files (DMF), Plant Master Files (PMF), Site Master Files (SMF), and Technical Files to keep submissions audit-ready.

I ensure compliance with Medical Device Rules (MDR 2017), ISO 13485, ISO 14971, and Good Manufacturing Practices (GMP). My responsibilities extend to batch-level and post-market readiness documents including Batch Manufacturing Records (BMR), Annual Compliance Reports (ACR), Instructions for Use (IFU), Declarations of Conformity (DoC), product labeling, SOPs, CAPA, Change Control, deviations, and risk assessments within the Quality Management System (QMS).

I support product registration and manufacturing license activities across India by conducting documentation reviews, gap assessments, regulatory query resolution, document control, and compliance coordination. I also conduct virtual and on-site client consultations, coordinate with manufacturers and cross-functional teams, and help clients prepare for regulatory inspections by managing audit documentation and driving closure of observations.

Experience

Work history, roles, and key accomplishments

Executive Regulatory Consultant

H L Associates

May 2025 - May 2026 (1 year)

Experienced in regulatory operations and compliance with ISO 13485, IMDR 2017, PMF, DMF, and technical documentation. Skilled in regulatory coordination, document preparation, and maintaining compliant records. Conducted site visits, frontline audits, and client coordination across Gujarat. Strong in stakeholder communication, audit support, and ensuring smooth execution.

Project Management Excel Microsoft Office Relationship Management Regulatory Submissions Client Communication Client Relationship Management Documentation Documentation Preparation Audit Support Audit Readiness Audit Management Project Leadership Team Coordination Pharmacy Operations Medical Devices Medical Device Compliance Legal Consulting

Executive Consultant Regulatory

H L Associates

May 2025 - May 2026 (1 year)

Worked in Medical Device Regulatory Affairs supporting compliance and regulatory documentation activities. Prepared and reviewed submissions and quality/regulatory documents for Indian MDR 2017 (CDSCO), EU MDR, and USFDA device registration, and supported audit handling and non-conformity resolution.

Medical Device Regulatory Affairs Regulatory Compliance CAPA SOPs Annexure Indian MDR 2017 (CDSCO)EU MDR Compliance Audits Client Coordination

Regulatory Affairs Intern

SV Healthcare

Jul 2024 - Sep 2024 (2 months)

Completed a 3-month internship in the Regulatory Affairs (RA) department supporting regulatory-related work at SV Healthcare.

ADL Department Trainee

Emcure Pharmaceuticals Limited

Jun 2022 - Jul 2022 (1 month)

Completed a 1-month training period in the ADL department at Emcure Pharmaceuticals Limited.

Education

Degrees, certifications, and relevant coursework

CHARUSAT

Master of Pharmacy , Drug Regulatory Affairs

2023 - 2025

Grade: 8.09

Activities and societies: Pursued M.Pharm in Regulatory Affairs with a strong focus on pharmaceutical and medical device regulations. Gained academic knowledge of ISO 13485, Indian MDR 2017, EU MDR, US FDA, ICH guidelines, eCTD, dossier preparation, QMS, and risk management. Completed research projects, technical documentation, seminars, and presentations while developing analytics & regulatory skills.

Gold Medalist in M.Pharm (Regulatory Affairs) with First Rank at the university. Awarded the Gold Medal by the Hon'ble Union Home Minister of India, Shri Amit Shah. Secured 2nd Rank in B.Pharm Semester V and VIII, won 1st Prize in Pharma Quiz, and received recognition for poster presentation and academic excellence throughout the program.

Charotar University of Science and Technology

Master of Pharmacy (Regulatory Affairs), Regulatory Affairs

Grade: 8.09 (CGPA)

Activities and societies: M.Pharm research: dossier preparation/compilation of diclofenac sodium suppository for Myanmar with regulatory insights and dosage-form comparison (Sem 4). Internship: 3 months in RA department at SV Healthcare, Makarba, Ahmedabad (Jul 2024–Sep 2024).

Gold Medalist M.Pharm in Regulatory Affairs from Charotar University of Science and Technology (Ramanbhai Patel College of Pharmacy), completed in 2025; CGPA 8.09.

Gujarat Technological University

Bachelor of Pharmacy, Pharmacy

Grade: 7.94 (CGPA)

Activities and societies: B.Pharm research projects: preparation/evaluation of polyherbal hair oil cosmetic (Sem 8) and method development of vildagliptin + metformin combined tablet dosage form (Sem 7). Industrial training: 1 month in ADL department at Emcure Pharmaceuticals Limited, Gandhinagar (Jun 2022–Jul 2022).

B.Pharm from Gujarat Technological University (B.M. Shah College of Pharmaceutical Education and Research), completed in 2023; CGPA 7.94.