Lokesha R M — Operations Associate

Results-driven Quality and Compliance Specialist with extensive experience in medical device testing, validation, and regulatory adherence. Skilled in wet chemical analysis, melting range determination, and LOD, with hands-on expertise in advanced analytical instruments including HPLC, GC, KF Titration, NMR, and IR. Proficient in method and process validation for pre-filled pens (Class I & II devices), stability and in-use studies, and performance testing such as friction force analysis and dose accuracy. Strong command of ISO 13485, IEC 62304, ISO 11608, and ISO 14971 standards, ensuring compliance across all phases of product lifecycle. Experienced in IQ/OQ/PQ execution, preparation and review of SOPs, protocols, specifications, and reports, and maintaining critical documentation like Design History Files (DHF), Device Master Records (DMR), and technical files. Adept at Post-Market Surveillance (PMS), Human Factors Engineering (HFE), and usability engineering documentation. Expert in risk management planning, sterilization gap assessments (MDD to MDR), and handling CTD, export documentation, and labeling requirements. Skilled in data analysis and visualization using Tableau and Qlik Sense, supporting PMS reporting and management reviews. Proven ability to train and mentor teams, manage customer queries and complaints, and coordinate with vendors for AMC and preventive maintenance. Committed to data integrity, GLP, and good documentation practices, driving continuous improvement in product performance, quality, and compliance. Specialized in PMCF planning and execution, clinical data analysis, and CER preparation and maintenance per EU MDR and MEDDEV guidelines. Passionate about delivering safe, effective, and compliant medical devices that improve patient outcomes.

Stackforce AI infers this person is a Quality and Compliance Specialist in the Healthcare industry.

Location: Hyderabad, Telangana, India

Experience: 8 yrs 3 mos

Skills

Regulatory Affairs
Quality Management

Career Highlights

Expert in regulatory compliance for medical devices.
Proven ability in method validation and quality management.
Strong analytical skills with data visualization expertise.

Work Experience

Sandoz

Associate Manager - Global MS&T (1 yr 8 mos)

Device Expert - Global MS&T Sandoz TechOps (1 yr 3 mos)

Novartis

Specialist- MS&T Operation Services (1 yr)

HCLTech

Lead Engineer - Subject Matter Expert Medical Device (8 mos)

Biocon Biologics

Quality Specialist - Medical Device (1 yr 4 mos)

Micro Labs Limited

Officer - Corporate Quality Control (1 yr 11 mos)

Biocon

Internship Trainee (5 mos)

Education

Master of Science - MS at University of Mysore

Bachelor of Science - BS at University of Mysore

Lokesha R M

Operations Associate

Hyderabad, Telangana, India8 yrs 3 mos experience

Most Likely To Switch

Key Highlights

Expert in regulatory compliance for medical devices.
Proven ability in method validation and quality management.
Strong analytical skills with data visualization expertise.

Stackforce AI infers this person is a Quality and Compliance Specialist in the Healthcare industry.

Contact

Skills

Core Skills

Regulatory AffairsQuality Management

Other Skills

Wet Chemical AnalysisMelting Range AnalysisLoss on Drying (LOD)HPLCGCKF TitrationNMRIRISO 13485IEC 62304ISO 11608ISO 14971Stability StudiesIn-Use StudiesMethod Validation

About

Experience

8 yrs 3 mos

Total Experience

1 yr 4 mos

Average Tenure

2 yrs 11 mos

Current Experience

Sandoz

2 roles

Associate Manager - Global MS&T

Promoted

Sep 2024 – Present · 1 yr 8 mos · Hybrid

Wet Chemical Analysis, Melting Range Analysis, Loss on Drying (LOD).
Skilled in handling analytical instruments: HPLC, GC, KF Titration, NMR, IR.
Strong knowledge and compliance with ISO 13485, IEC 62304, ISO 11608, ISO 14971 standards.
Expertise in Stability Studies and In-Use Studies for medical devices.
Method Validation & Process Validation for Pre-filled Pens (Class I & II devices).
Proficient in Friction Force Analysis and Dose Accuracy Testing for single-use and reusable pens.
IQ/OQ/PQ performance and documentation.
Preparation and review of SOPs, Specifications, Protocols, Reports.
Sampling of devices as per relevant standards.
Maintenance of Design History File (DHF), Technical Documentation, Device Master Record (DMR).
Contribution to Post-Market Surveillance (PMS), Human Factors Engineering (HFE), and usability engineering documents.
Adherence to Data Integrity Policy, Good Documentation Practices (GDP), and GLP.
Sterilization Standard Gap Assessment (MDD to MDR).
Handling CTD, export documentation, and labeling requirements.
Preparation and update of PMS plans, reports, and quarterly reviews.
Risk Management Plan/Report preparation and maintenance.
Handling customer queries and complaints related to product quality.
Coordination with vendors for AMC and Preventive Maintenance (PM) of instruments.
Ensuring customer satisfaction through effective service delivery.
Collect, analyze, and present data using Tableau, Qlik Sense for PMS and quality reports.
Assessment of health authority safety databases for post-market surveillance.
Communicate review recommendations to management during Management Reviews.
Train, mentor, and onboard personnel for Quality Operations.
Drive continuous improvement in product performance, quality, and compliance.
Develop and implement Post-Market Clinical Follow-up (PMCF) plans in compliance with MDR requirements.
Collect and analyze clinical data to monitor device performance and safety post-market.

Wet Chemical AnalysisMelting Range AnalysisLoss on Drying (LOD)HPLCGCKF Titration+27

Device Expert - Global MS&T Sandoz TechOps

May 2023 – Aug 2024 · 1 yr 3 mos · Hybrid

I am adept at preparing, reviewing, and maintaining quality records, including Design History Files (DHF), Technical Documentation, and Device Master Records (DMR). I contribute to the maintenance and review of Sandoz medical device technical documents, including DHF, Post-Market Surveillance (PMS), and Human Factors Engineering (HFE) / usability engineering documents.
Prepared and updated post market surveillance (PMS) plan and reports for medical devices.
Analyzed and presented data using visualization tools to support report preparation.
Coordinated PMS data quarterly reviews and communicated recommendations to Management Representatives.

Quality RecordsPost-Market Surveillance (PMS)Data AnalysisVisualization ToolsRegulatory AffairsDevice Master Record (DMR)+2

Novartis

Specialist- MS&T Operation Services

Apr 2022 – Apr 2023 · 1 yr · Hyderabad, Telangana, India · Hybrid

Prepared and updated PMS plan and reports for medical devices:
Developed and maintained comprehensive PMS plans, ensuring they comply with regulatory requirements.
Regularly updated these plans based on new data, regulatory changes, and feedback from stakeholders.
Analyzed and presented data using visualization tools to support report preparation:
Utilized various data visualization tools (like Excel, Tableau, or Power BI) to analyze PMS data.
Created clear and informative visual reports that highlighted key findings and trends, making it easier for stakeholders to understand the data.
Coordinated PMS data quarterly reviews and communicated recommendations to Management Representatives:
Organized and led quarterly reviews of PMS data, ensuring all relevant data was collected and analyzed.
Communicated your findings and recommendations to Management Representatives, helping them make informed decisions about product safety and performance.

Post-Market Surveillance (PMS)Data AnalysisVisualization ToolsRegulatory AffairsQuality Management

Hcltech

Lead Engineer - Subject Matter Expert Medical Device

Jul 2021 – Mar 2022 · 8 mos · Chennai, Tamil Nadu, India · Hybrid

Led quality assurance efforts for medical devices, ensuring compliance with ISO standards and handling customer complaints.
Conducted sterilization standard gap assessments and maintained quality records for regulatory requirements.

Quality AssuranceISO StandardsCustomer ComplaintsSterilization Standard Gap AssessmentsRegulatory AffairsQuality Management

Biocon biologics

Quality Specialist - Medical Device

Mar 2020 – Jul 2021 · 1 yr 4 mos · Bengaluru, Karnataka, India · On-site

Conducted wet chemical analysis, melting range analysis, and handling of instruments like HPLC, GC, KF Titration, NMR, and IR for medical devices.
Ensured adherence to ISO standards, stability studies, and method validation for pre-filled pens.
Led customer complaint handling, quality record maintenance, and coordination with vendors for instrument maintenance.
Handling of Incoming and Finished Medical Devices and In-Process Samples
Knowledge and Adherence: Familiar with ISO 13485, ISO 9001, ISO 11608, and ISO 14971 standards.
Stability and In-Use Studies: Conducted stability and in-use studies for medical devices, specifically insulin prefilled pens.
Method and Process Validation: Executed method validation and process validation for prefilled pens (Class I and II devices).
Injection Force Testing: Performed injection force tests for prefilled pens.
Friction Force Testing: Conducted friction force tests for insulin cartridges and prefilled pens, including break-loose and glide force tests for prefilled syringes.
Dose Accuracy Testing: Carried out dose accuracy tests for prefilled pens.
IQ/OQ/PQ Performance: Knowledgeable in the performance of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Regulatory Reporting: Shared quality summary data with regulatory bodies.
Documentation: Managed Device History Files (DHF), Device Master Records (DMR), design verification, and design validation. Proficient in technical documentation of DHF.
Product Lifecycle Management: Experienced in managing the medical device product lifecycle.
Quality Control Documentation: Prepared Quality Control Standard Operating Procedures (SOPs), specifications, protocols, and reports.
Quality Records Maintenance: Prepared, reviewed, and maintained quality records.
Complaint Handling: Managed and resolved complaints related to medical devices.