NIMISHA SINGH

+1-646-***-**** Belle Mead, New Jersey

adye6p@r.postjobfree.com

SUMMARY

Dedicated professional with a solid foundation in software engineering, seeking to transition into a rewarding career in regulatory affairs. Possessing result-oriented approach, strong aptitude for research, analysis, and attention to detail, I bring a robust skill set that can be leveraged to excel in the regulatory environment. Experience and expertise in Process analysis, Quality management, Quality assurance and software development. Demonstrated ability to quickly grasp complex concepts and effectively communicate regulatory requirements to diverse stakeholders. Proactive and results- oriented, I am committed to ensuring compliance with applicable laws, regulations, and guidelines while navigating the evolving regulatory landscape. Pursuing regulatory affairs certificate for medical devices from RAPS to obtain a formal educational training in the field. Seeking to contribute expertise and drive regulatory excellence in a dynamic organization.

SKILLS

• Expertise in Quality management system, process analysis and CMMi standards.

• Obtaining formal training in ethics, global regulatory strategy for medical devices, definition and lifecycle of medical devices, role, US and EU regulations, Advertising and promotion in the US, Project management for regulatory professionals, and regulatory due diligence for product development

• ‘CDRH learn’ certification on medical devices regulatory requirements.

• Well versed with cGMP, cGLP, cGCP aspects.

• Meticulous documentation skills and dedicated achiever with strong analytical/problem-solving abilities.

• Self-directed initiator with ability to collaborate with the team as well as work independently.

EXPERIENCE

JULY 09 – TODAY

PROFESSIONALLY ACTIVE CAREER BREAK/ ENTREPRENEUR

• Attended relevant US FDA webinars- US FDA Regulatory Education for Industry

(REdI) Annual Conference

2

• Actively engaged in the field of Regulatory Affairs by completing online courses on regulatory requirements for medical devices offered through CDRH Learn, thereby supporting career transition-

o 510(k) and 513(g)

o Establishment registration and device listing

o Quality systems regulations 21 CFR part 820

o Export certificate for medical devices

o Medical device reporting

• Actively pursuing RAPS certification for medical devices with focus on following modules:

o Ethics,

o Global regulatory strategy for medical devices

o Medical devices: definition and lifecycle

o Role of the regulatory professional

o US regulations

o EU regulations

o Advertising and promotion in the US

o Project management for regulatory professionals

o Regulatory due diligence for product development

• Enhanced and fine-tuned planning, management, multi-tasking and troubleshooting skills and developed patience and gratitude.

• Worked with WCEC (Women’s center for entrepreneurship corporation) for starting a business to secure funds and support a nonprofit charitable cause. MAY 04 – JUNE 09

IT PROFESSIONAL

Worked in various aspects of software development including development, Quality assurance and Processes. Worked as Process Analyst in the last role. Few work areas were:

• Reviewed compliance and worked on defining guidelines for corporate processes as per CMMI guidelines.

• Ensured process compliance across business units as per the Corporate Quality Management process guidelines.

• Trained projects on processes, documentation and reporting.

• Analyzing, defining requirements. Working on developing solutions and testing adherence.

EDUCATION

2023

CDRH LEARN CERTIFICATION

RAPS CERTIFICATION FOR MEDICAL DEVICES (CURRENTLY PURSUING) 3

NJ NOTARY

CERTIFIED SCRUM MASTER FROM SCRUMALLIANCE

2006

MASTERS IN COMPUTER APPLICATIONS, CIIT -JAIPUR, INDIA 2004

BACHELORS IN COMPUTER APPLICATIONS, CIIT -JAIPUR, INDIA 2002

A LEVEL – DEPT. OF ELECTRONICS, INDIA

2001

O LEVEL – DEPT. OF ELECTRONICS, INDIA

Contact this candidate