Director, Regulatory Affairs

Contego Medical, LLC Located in: Raleigh,  North Carolina
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Contego Medical, LLC Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Responsible for implementing the regulatory strategies that will allow the company to market its products worldwide through the preparation of global regulatory submissions. 

Duties & Responsibilities:

  • Develop and implement regulatory strategies and processes to support global commercialization of the company’s products including product registrations, notifications, investigational device exemptions, 510(k) submissions and pre-market approvals.
  • Interface with regulatory authorities and notifed bodies.
  • Support notified body audits and/or FDA inspections.

CRITICAL REQUIREMENTS

    • Bachelor's degree in biology or a related field of study.
    • 10 years of relevant experience in regulatory affairs and quality assurance in the medical device industry.
    • Cardiovascular device experience required.
    • Class II and III vascular medical device experience is strongly preferred.
    • Experience with device submissions (technical files, design dossiers, 510(k)s, PMAs) and interaction with regulatory bodies.
    • Strong written and verbal communication skills.
     

COMPANY INFORMATION

Contego Medical, LLC is a medical device company poised to disrupt the field of endovascular medicine. The Company’s Integrated Embolic Protection technology has been uniquely designed to address unmet needs in peripheral and cardiovascular procedures. The core benefit of this platform technology is the integration of embolic protection onto the same catheter as the treatment portion (i.e., balloon or stent). Contego has amassed a team of highly seasoned medical device professionals to manage this effort, led by Founder and CEO Ravish Sachar, MD, FACC. The Company is positioned for growth in a number of target markets and geographies over the next several years.

JOB INFORMATION

Seniority Level:
Director / VP
Function:
  Regulatory Affairs
Preferred Industry Background:
  Medical Device
Managing a team of:
N/A
Required Travel:
Very Little - 1 week per month

Base Salary:
90,000 To 130,000 USD PER year
Bonus:
Benefits:
Standard
Other Compensation:
Education Required:
Undergraduate
Therapeutic Experience:
Cardiovascular
Class of Device:
Class 3
International Experience:
UK / Europe,North America