Packaging / Compliance Coordinator (HYBRID)

Overview

Hybrid
Depends on Experience
Contract - W2
Contract - 12 Month(s)

Skills

Document management
regulatory submissions
product compliance
national/regional/global regulations
license renewal
risk management
labeling review
marketing materials
clinical trials
compliance programs
customer inquiries
regulatory updates
external body representation.

Job Details

Please note that this is a 6 to 12-month contract position.

Only local candidates need to apply.

Can work remotely as long as the candidate is local to Denver, Frederick, or Boulder, Colorado.

Job Posting Qualifications

  • Bachelor's Degree, with minimal to no prior relevant work experience or equivalent experience (1-4 years) with document management systems or regulatory submissions.

Job Posting Description

  • 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.

Applicants must provide their phone number. Reference job number A4742.

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