Headline

R&D Regulatory Affairs Specialist (Medical Device), EU MDR 2017/745 | FDA 21 CFR Part 820 | ISO 13485 | ISO 14971 | ISO 11607 | Labeling & Packaging | QAQC | CAPA | Compliance Handling | Risk Management

About

Experienced Regulatory Affairs Specialist in the field of medical devices with a strong track record of ensuring compliance and driving successful EU MDR & UK MDR, Labeling design, complaints handling and change management projects with 4 years of dedicated industry experience, I am passionate about navigating the ever-evolving regulatory landscape to bring innovative healthcare solutions to market. My expertise lies in interpreting and implementing MDR requirements, collaborating cross-functionally, and delivering on-time, quality submissions. Let’s connect to discuss how my skills can contribute to your team’s success in achieving regulatory excellence and product safety in the medical device industry.

Location

Chennai

AI stack

claude code

openai

Adobe Firefly

ChatGPT

Work experience

Quality Analyst at ICU Medical, Nov 2025 - Present · 11 mos, Chennai, Tamil Nadu, India

Senior Process Associate at GENPACT, Jan 2025 - Jun 2025 · 6 mos

Regulatory Specialist at HCLTech, Oct 2022 - Jan 2025 · 2 yrs 4 mos, Chennai, Tamil Nadu, India, Project: EU MDR Remediation (Specialty Gap Assessment): • Hands on experience in change control management, particularly in handling material/design changes, and supplier changes. • Experience in performing Design History file (DHF) remediation taszzks, preparing DHF Indexes and conducting DHF reviews to ensure its compliance as per guidelines. • Possess understanding of both pre and post submission notified body activities, including updates related to deficiencies based on notified body comments. • Familiar in writing the technical documents, Clinical Evaluation and Post Market Surveillance data concerning to a medical device. • Familiarity with various PLM tools associated with the project. • Possess knowledge on various methods of sterilizations (like - EO Sterilization, Radiation Sterilization, and Steam Sterilization) and its validations. • Possess Knowledge in the various test methodologies for validating the packaging of a medical device. • Performed EU MDR Gap assessment as part of Remediation activities in terms of Sterilization & Packaging for various medical devices as per ISO 11607. • Handling the team with quality aspect as a Defect Prevention Analyst, and as a Configuration Controller. • Having knowledge in EU MDR 2017/745, ISO 13485, ISO 14971, ISO 11607, and ISO 14644. • Discussing on the queries and continuous improvement points with the stake holders.

Education

Bachelor of Technology - BTech, Mechanical Engineering, SRM IST Chennai