Brain Power Job Application – Quality Assurance and Regulatory Affairs

Thank you for your interest in Brain Power’s positions related to Quality Assurance, Quality Management, and Regulatory Affairs.
Other listings are on our jobs page. Contact: job-applications @ brain-power.com.    Good luck!!

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YOUR BACKGROUND:

This position is in Cambridge, MA.
Do you live in the area or will you be able to relocate?
YesNo

Desired Position: Quality Assurance and Regulatory Affairs Project ManagerQARA Part-Time Consultant

 

Don't worry about not having ALL the skills listed below.
Also, feel free to note any talents not listed by mentioning them in the free-response fields at the bottom.

Please accurately rate your Expertise or Level   (5 is best):

PROJECT MANAGEMENT & TEAM SKILLS

Managing Teams:

Managing Projects:

Training Others:

Self-Guided Learning:

Record-Keeping:

Document Management:

Agile/Scrum Experience:

DevOps:

 

Task Timeliness:

Startup Experience:

Ability to Keep Secrets:

Positive Attitude:

Willingness to Work:

Enthusiasm:

Passion:

Dedication & Loyalty:

REGULATORY EXPERTISE

Quality Management Systems:

FDA Regulatory Compliance:

FDA Regulatory Strategy:

FDA Law:

Regulatory Submission Writing:

Regulatory Submission Lifecycle:

 

Requirements Gathering:

Complaint Handling:

FDA Design Controls:

Launching New Med Device:

CAPA Proceedings:

FDA Audits:

 

ISO 13485:

ISO 14971:

IEC 62304:

21 CFR 820:

 

Medical Device experience:

Digital Therapeutics:

Scientific Writing:

Marketing Writing:

 
SOFTWARE & TOOLS

Any QMS Software:

Greenlight Guru:

 

Productivity Software (any):

JIRA:

Trello:

Slack:

 

Version Control (e.g Git, SVN, etc):

Google Drive:

Microsoft Office:

Dropbox:

 

PREFERRED PLATFORM / OS:

Primary OS:

Windows Proficiency:

Mac Proficiency:

Linux Proficiency:

 

FREE-FORM RESPONSE FIELDS:
No single one of these is required, but please do not leave them all blank.

 

 

Résumé

Please upload your résumé, named LASTNAME_FIRSTNAME_resume.pdf.

 

After initial review, you may be contacted for further screening.


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