Medical Device Regulatory Expert

Greetings!!!
Welcome to TechProjects. We specialize in IT system integration, supporting major public sector clients across New York State. Our focus is on delivering high-quality technology solutions while creating strong career opportunities for our employees.
We are currently hiring and looking for talented tech professionals who are eager to work on impactful and innovative projects. We offer competitive compensation, excellent benefits, and opportunities for professional growth.
We look forward to connecting with you and exploring how you can be a part of our team. 
 
Job Title: Medical Device Regulatory Expert Location: Remote Duration: Long term
 
Description of Role and Responsibilities: The Ancillary Associate is responsible in arranging the 

• -Legal Documents (CPP, Manufacturing License, GMP, FSC& other documents) from respective Issuing Authorities for submission purposes. 

• -Upload the final documents into the Veeva Vault.

 Responsibilities:

• Compiling the applications, reviewing, printing and Submission of documents to Health Authorities and coordination for final Ancillary documents.

• Coordinating with Manufacturing Sites and Vendors in arranging of Notarization/Apostillation/ Legalization in line with countries requirements.

• Coordination with the requestors to dispatch the final documents

• Archiving the Final Document to Veeva Vault RIM

• Plan the due dates and coordinate the on-time delivery of the document, to meet regulatory submission timelines.

• Prepares status reports, final reports and metrics for Ancillary Documentation activities.

 Required Skills

• Bachelor's degree required in science, engineering or related field.

• Basic Knowledge on the Pharmaceutical terminology. Should aware of administrative documents like CPP, GMP, Manufacturing license.

• Proficient in languages- English/French

• Experience with Veeva Vault/RIM is an advantage.

• Proven oral and written communication skills and the ability to communicate issues in a succinct and logical manner with strong listening skills.

• Ability to generate innovative solutions to issues and effectively work with and communicate to key stakeholders.