Senior Regulatory Affairs Specialist

Regulatory and Quality Solutions LLC (R&Q) Located in: Newark,  New Jersey
(Private and Secure - Guaranteed!)

Regulatory and Quality Solutions LLC (R&Q) Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

R&Q is currently looking to add a Senior Regulatory Specialist to our team. This team member will work on an immediate project in the Northern New Jersey area.  Team member will sit on NPD teams at our client site and dictate regulatory strategy.  Team member will be responsible for  510(k)’s (if any), non-filing justifications, updating tech files for CE marking, and communicate information to OUS affiliates for registrations. This project could be a full time role with R&Q for someone that is open to travel through out R&Q's business markets.

CRITICAL REQUIREMENTS


    •         
    • Bachelor level degree in engineering or chemistry, physics, biology or related life science 

    •         
    • 2-5 years experience working in a Regulatory department for a Medical Device Manufacturer

    •         
    • Consulting experience preferred

    •         
    • Working knowlege in one or more key Regulatory areas 510K, EU Technical Files, Canadian licensing

    •         
    • Effective communication skills 

COMPANY INFORMATION

Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality consulting and engineering to medical device companies.

JOB INFORMATION

Seniority Level:
Entry-Level
Function:
  Regulatory Affairs
Preferred Industry Background:
  Medical Device
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Comprehensive Medical, STD, company paid life insurance and PTO for Full time and Project Employee
Other Compensation:
Education Required:
Undergraduate
Class of Device:
Class 2
International Experience:
UK / Europe