Regulatory Affairs Specialist
  • Franklin Lakes, New Jersey, US
  • +914043515100
450 Days ago
Job Description

Roles & Responsibilities:

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.
  • Leads or compiles all materials required in submissions, license renewal, and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and the clinical protocol for regulatory compliance.
  • Monitors and improves tracking/control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for the earliest possible approvals of clinical trial applications.

Job Skills:

  • Knowledge of FDA, EU, MHLW, and TGA requirements
  • US FDA PMA, 510(k) and European Union submission experience (desired)
  • Strong communication skills
  • Strong technical writing skills

Education and Experience:

  • Bachelor's degree in related field; Regulatory Affairs Certification (desired)
  • 5 years of the significant US and International medical device submission experience and/or regulatory affairs experience.
Industry
  • NA

Required Skills
  • Regulatory Affairs Specialist

Experience
  • 5 Years of Experience

Salary
  • NA

Working Hours / Week
  • 40h