Rutuja Mane
Pune
Summary
Versatile professional with a strong foundation in regulatory frameworks and quality assurance. Known for effective technical writing and collaboration with R&D teams to align product development with compliance requirements, driving successful outcomes in the medical device industry.
Overview
3
3
years of professional experience
5
5
Certifications
Work History
Regulatory Executive
Shreeyash Electro Medicals
Pune
04.2024 - Current
- Prepared and managed technical files, DMF, and PMF for Class A, B, and C medical devices.
- Coordinated with CDSCO for product registration, licensing, and regulatory submissions.
- Ensured compliance with ISO 13485:2016, IEC standards, and MDR requirements.
- Supported product certification and licensing activities, contributing to successful market approvals.
- Conducted regulatory gap analysis and implemented corrective actions to strengthen compliance.
- Assisted in risk management (ISO 14971) and maintained QMS documentation.
- Led internal audits and stock audits, ensuring readiness for external inspections.
- Acted as Management Representative, bridging regulatory, quality, and leadership functions.
- Collaborated with R&D teams to align product development with regulatory requirements.
- Handled tender submissions and documentation for government and institutional clients.
- Uploaded and managed regulatory documents on CDSCO portals with accuracy and timeliness.
- Provided audit preparation and support, ensuring smooth certification processes.
Microbiologist
Sula Vineyard
Nashik
08.2022 - 08.2023
- Conducted microbiological testing and analysis of wine samples to ensure product safety and quality.
- Monitored fermentation processes, yeast cultures, and microbial activity to optimize wine production.
- Performed quality control checks on raw materials, in-process batches, and finished products.
- Maintained and calibrated laboratory equipment for accurate testing and compliance with standards.
- Prepared detailed lab reports and documentation for internal audits and regulatory compliance.
Education
Diploma in Clinical Research And Regulatory Affairs - Clinical Research And Regulatory Affairs Diploma
Clariwell Solution
Pune 03-2024
Master of Science - Microbiology
Yashwantroa Mohite Bharati Vidyapeeth
Pune 04-2023
Skills
- Regulatory compliance
- Risk management
- Product certification
- Quality management
- Technical writing
- Market analysis
- Team leadership
- Audit preparation
- Time management
Languages
English
Intermediate (B1)
B1
Hindi
Intermediate (B1)
B1
Marathi
Upper Intermediate (B2)
B2
Certification
ISO 13485:2016 And ISO 9001 Internal Auditor
Timeline
Regulatory Executive
Shreeyash Electro Medicals
04.2024 - Current
Microbiologist
Sula Vineyard
08.2022 - 08.2023
Diploma in Clinical Research And Regulatory Affairs - Clinical Research And Regulatory Affairs Diploma
Clariwell Solution
Master of Science - Microbiology
Yashwantroa Mohite Bharati Vidyapeeth