PRADNYA DANGAT

Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

· Appeared for general and advanced INTELLECTUAL PROPERTY RIGHTS courses by WIPO.

· Good knowledge in developing regulatory strategies and preparing regulatory submissions (domestic and international) for Class II and Class III (FDA classification scheme) medical devices and European medical device submissions, regulations, and standards

· Good knowledge in IDEs, PMAs, 510(k)s, Amendments, Supplements, Annual Reports, Design Dossiers, Technical Files and Notification to Notified Bodies.

· Good knowledge of medical device regulations with an emphasis on FDA and MDD(EU).

· Completed training on Mastering Quality Assurance Documents sponsored by Amicon rx trarning institute for skill development.

· Excellent project management skills including meeting facilitation, organization and time management

· Poster Presentation in International INDO GERMAN METABOLIC MEET CONFERENCE(IGMM) on

‘Thiamine Deficiency in Infants’ in 2017

· Research paper published in ‘Wiley Biomedical chromatography journal ‘on topic ‘Development

and validation of a dried blood spot test for thiamine deficiency among infants by HPLC-

Flourimetry’.

I hereby confirm that the above is true to the best of my knowledge. 

Pradnya Dangat

Place – Pune