Sam Rajkumar Email & Phone Number | Regulatory Affairs & Quality Assurance Professional with diverse experience and a solid record of positive contributions in medical device, academic, consulting, and hospital settings. • Skilled in Regulatory Submissions, Internal Audits, Process Quality Improvement, and Quality Management. • Passionate and driven Medical Science Professional with a Master of Science focused on Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University. • Effective interpersonal, communication (spoken, written, presentation), and leadership skills have proven highly valuable in partnering with cross-functional teams and diverse internal and external stakeholders in managing multiple priorities / projects in rapidly changing and demanding environments. • Strong research skills with excellent attention to detail are put to good use in problem solving complex issues and arriving at viable solutions. • Extensive experience with and knowledge of: - Wide range of medical devices, including Cardiac and Spine Implants, Surgical Robotics, SaMD, etc. - European Union Medical Device Regulations and MDD 93/42/EEC. - Authoring and project managing complex submissions for global regulatory agencies, including IDE/IDA, 510(k), Modular PMA, CE Technical File-Design Dossier, and Chinese, Canadian, and Japanese submissions. - Registering products in complex emerging markets within Middle East, Latin America, and Asia Pacific. - Post-market surveillance activities, including complaint handling, recalls, and adverse event reporting. - Designing and implementing quality management systems in medical device start-ups and mid- sized organizations, and leading successful MDSAP and ISO 13485:2016 implementations. - Building healthy and effective working relationships with FDA, Health Canada, UK’s MHRA, and other regulatory agencies. - Design Control, CAPA, NCR, Complaint Handling and MDR, and Risk Management. - Authoring and compiling clinical study submission packages, including study protocol, informed consent, case report, and adverse event reporting forms.

Sam Rajkumar

Regulatory Affairs & Quality Assurance Professional with diverse experience and a solid record of po...
Greater Boston, Greater Boston, United States

*50 free lookup(s) per month.

No credit card required.

Sam Rajkumar’s Email srajkumar@exactimaging.com

Sam Rajkumar’s Phone Numbers

Get SAM’s Phone Number (For Free)

Social Media

Sam Rajkumar’s Location Greater Boston, Greater Boston, United States

Sam Rajkumar’s Current Industry Analog Devices Northeastern University

Not the Sam Rajkumar you were looking for?

Find accurate emails & phone numbers for over 700M professionals.

Work Experience

Analog Devices

Director, Regulatory Affairs & Quality Assurance & Security (Digital Healthcare)

2024-04-01 00:00:00 - Present

Northeastern University

Adjunct Faculty

2019-07-01 00:00:00 - Present

Medtronic

Senior Regulatory Affairs Specialist

2020-03-01 00:00:00 - 2021-05-01 00:00:00

Exact Imaging

Consultant, Manager, Regulatory Affairs and Quality Assurance

2020-02-01 00:00:00 - 2021-03-01 00:00:00

Sam Regulatory Consulting

Regulatory and Quality Consultant

2016-09-01 00:00:00 - 2019-12-01 00:00:00

Synaptive Medical

Regulatory Affairs Specialist

2016-01-01 00:00:00 - 2019-01-01 00:00:00

The Hospital For Sick Children

Graduate Research Associate

2015-01-01 00:00:00 - 2016-01-01 00:00:00

Credit Valley Hospital

Registered Nurse, ICU

2013-01-01 00:00:00 - 2015-01-01 00:00:00

Grand River Hospital

Registered Nurse, Renal Unit

2012-01-01 00:00:00 - 2013-01-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Sam Rajkumar

Sam Rajkumar is located at
Greater Boston, Greater Boston, United States

Sam Rajkumar is a Regulatory Affairs & Quality Assurance Professional with diverse experience and a solid record of positive contributions in medical device, academic, consulting, and hospital settings. • Skilled in Regulatory Submissions, Internal Audits, Process Quality Improvement, and Quality Management. • Passionate and driven Medical Science Professional with a Master of Science focused on Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University. • Effective interpersonal, communication (spoken, written, presentation), and leadership skills have proven highly valuable in partnering with cross-functional teams and diverse internal and external stakeholders in managing multiple priorities / projects in rapidly changing and demanding environments. • Strong research skills with excellent attention to detail are put to good use in problem solving complex issues and arriving at viable solutions. • Extensive experience with and knowledge of: - Wide range of medical devices, including Cardiac and Spine Implants, Surgical Robotics, SaMD, etc. - European Union Medical Device Regulations and MDD 93/42/EEC. - Authoring and project managing complex submissions for global regulatory agencies, including IDE/IDA, 510(k), Modular PMA, CE Technical File-Design Dossier, and Chinese, Canadian, and Japanese submissions. - Registering products in complex emerging markets within Middle East, Latin America, and Asia Pacific. - Post-market surveillance activities, including complaint handling, recalls, and adverse event reporting. - Designing and implementing quality management systems in medical device start-ups and mid- sized organizations, and leading successful MDSAP and ISO 13485:2016 implementations. - Building healthy and effective working relationships with FDA, Health Canada, UK’s MHRA, and other regulatory agencies. - Design Control, CAPA, NCR, Complaint Handling and MDR, and Risk Management. - Authoring and compiling clinical study submission packages, including study protocol, informed consent, case report, and adverse event reporting forms.

Sam Rajkumar currently works in the Analog Devices | Northeastern University |

No Languages Available

Sam Rajkumar has prior
experience in the following industries:
Medtronic | Exact Imaging | Sam Regulatory Consulting | Synaptive Medical | The Hospital For Sick Children | Credit Valley Hospital | Grand River Hospital

Sam Rajkumar has the following professional experience:
Analog Devices | Northeastern University | Medtronic | Exact Imaging | Sam Regulatory Consulting | Synaptive Medical | The Hospital For Sick Children | Credit Valley Hospital | Grand River Hospital