Pubudi S.

Pubudi S.

ParisFrance
Job Success
Top Rated

Medical Device Consultant

Over 8 years experience in Regulatory Affairs, V&V and technical submissions for a range of medical devices, including orthopaedics, active implantable and novel, high-risk electromechanical systems. Responsible for authoring several 510(k) submissions for the FDA, including all relevant attachments and reports (clinical evaluations, FMEA risk management files, biocompatibilty reporting, process validations, labeling and packaging etc). Similarly, have authored several technical files and design dossiers for CE marking of Class IIa, IIb and Class III devices. Handled all subsequent follow-ups and questions from Notified Bodies, including on-site audits from both the FDA and BSI. Participated in pres-sub activities with the FDA for novel high-risk implants in the design phase, to establish regulatory pathway to First In-Human trials and subsequent PMA. Achieved and maintained registration of products in a range of jurisdictions including EU, US, Canada, Australia, Israel, Chile and Japan. Familiar with the application of a range of standards including ISO 13485, ISO 14971, IEC 60601, FDA 21 CFR Part 820, as well as upcoming changes in the new EU MDR. Well versed in the development and lodgement of Regulatory Files, and can complete activities such as literature searches, clinical evaluations ,predicate device comparisons, development of SOP's and other QMS documentation, as well as validations for processes such as sterilization (gamma and EtO), packaging, and Human Factors Engineering studies. I look forward to working with you!
Rating is 5 out of 5.
5.00 Apr 26, 2022 - May 3, 2022

"The assignment was delivered as per the agreed timing and standards. Highly recommend!"

Private earnings
Apr 26, 2019 - May 15, 2019

No feedback given

Private earnings
Rating is 5 out of 5.
5.00 Feb 6, 2019

"Ms. Silva is the consummate professional and a pleasure to work with.. she completed the project perfectly in an incredibly short period of time; her integrity and work ethic is easily appreciated in the final work that she produced. I look forward to working with her on future endeavors."

Private earnings

Pubudi S. has more jobs. Create an account to review them

Portfolio

FDA Medical Device Regulations Course
FDA Medical Device Regulations Course
EU Medical Device Regulations (MDR) Course
EU Medical Device Regulations (MDR) Course
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Skills

Pubudi S.

Pubudi S.

ParisFrance
Job Success
Top Rated
14
Total Jobs
87
Total Hours

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Medical Device Consultant

Specializes in
Over 8 years experience in Regulatory Affairs, V&V and technical submissions for a range of medical devices, including orthopaedics, active implantable and novel, high-risk electromechanical systems. Responsible for authoring several 510(k) submissions for the FDA, including all relevant attachments and reports (clinical evaluations, FMEA risk management files, biocompatibilty reporting, process validations, labeling and packaging etc). Similarly, have authored several technical files and design dossiers for CE marking of Class IIa, IIb and Class III devices. Handled all subsequent follow-ups and questions from Notified Bodies, including on-site audits from both the FDA and BSI. Participated in pres-sub activities with the FDA for novel high-risk implants in the design phase, to establish regulatory pathway to First In-Human trials and subsequent PMA. Achieved and maintained registration of products in a range of jurisdictions including EU, US, Canada, Australia, Israel, Chile and Japan. Familiar with the application of a range of standards including ISO 13485, ISO 14971, IEC 60601, FDA 21 CFR Part 820, as well as upcoming changes in the new EU MDR. Well versed in the development and lodgement of Regulatory Files, and can complete activities such as literature searches, clinical evaluations ,predicate device comparisons, development of SOP's and other QMS documentation, as well as validations for processes such as sterilization (gamma and EtO), packaging, and Human Factors Engineering studies. I look forward to working with you!
Rating is 5 out of 5.
5.00 Apr 26, 2022 - May 3, 2022

"The assignment was delivered as per the agreed timing and standards. Highly recommend!"

Private earnings
Apr 26, 2019 - May 15, 2019

No feedback given

Private earnings
Rating is 5 out of 5.
5.00 Feb 6, 2019

"Ms. Silva is the consummate professional and a pleasure to work with.. she completed the project perfectly in an incredibly short period of time; her integrity and work ethic is easily appreciated in the final work that she produced. I look forward to working with her on future endeavors."

Private earnings

Pubudi S. has more jobs. Create an account to review them

Portfolio

FDA Medical Device Regulations Course
FDA Medical Device Regulations Course
EU Medical Device Regulations (MDR) Course
EU Medical Device Regulations (MDR) Course
Want to see more? Create Account

Skills

As Needed - Open to Offers