Regulatory - Expert in Frederick, MD at Volt

Date Posted: 4/16/2021

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Frederick, MD
  • Duration:
    48 weeks
  • Date Posted:
    4/16/2021
  • Job ID:
    264064
  • Pay Rate
    $52.1/Hour
  • Contact Name
    Volt Branch
  • Phone
    (781) 496-4360

Job Description

Regulatory Expert 

We are looking for someone with strong knowledge and experience with the new IVDR regulations.   Here are some other considerations:

  • Proficient in Project Management Skills for R&D Product Development
  • Excellent Communication Skills (Written and Verbal)
  • Advanced Understanding of Product Safety Risk Management and Post Market Surveillance
  • Advanced Understanding of the EU IVDR Regulations and other country regulations
  • Understanding of Performance Evaluation Plans and Reports
  • Understanding of Product Requirements, Specifications and Intended Use

Responsibilities:

  • Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
  • Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.
  • Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
  • Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.
  • Reviews product labeling and marketing materials for accuracy and compliance with regulations.
  • Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
  • Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
  • May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.
  • Reduces broad concepts, business strategies into structure projects.
  • Leads the design/ delivery of new programs/ solutions; is the key technical contributor.
  • Solves complex, high impact program/ project design problems.

VOLT is an equal opportunity employer.