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Regulatory Affairs Specialist
LanceSoft Inc Montvale, NJ
$115k-147k (estimate)
Contractor | Business Services 2 Days Ago
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LanceSoft Inc is Hiring a Regulatory Affairs Specialist Near Montvale, NJ

Job Description...
Responsibilities:
  • RA representative on the R&D cross functional team
  • Identifies standards and target country regulations for the design team
  • Review Engineering changes including registration impact, risk assessments and review and approve engineering change orders and project documentation
  • Prepare regulatory submissions, technical files and international product registration documents as needed.
  • Regulatory support for business systems including ERP change management (Form 239).
  • Facilitate all FDA registration and listing related activities
  • ACE Index Support for Import and Export
  • Manage Recall/Field Action Activities
Minimum Qualifications: Bachelors degree in Life Sciences or a related field Three-five years experience in Regulatory Affairs for a medical device company Regulatory Affairs Certification (preferred) Thorough understanding of domestic and international regulatory requirements for medical devices Excellent problem solving and verbal and written communication skills Must be self-motivated and detailed oriented

Job Summary

JOB TYPE

Contractor

INDUSTRY

Business Services

SALARY

$115k-147k (estimate)

POST DATE

06/01/2024

EXPIRATION DATE

11/17/2024

WEBSITE

lancesoft.com

HEADQUARTERS

HERNDON, VA

SIZE

500 - 1,000

FOUNDED

2000

TYPE

Private

CEO

DIVYA GANDHI

REVENUE

$200M - $500M

INDUSTRY

Business Services

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About LanceSoft Inc

LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.

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