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Regulatory (Expert) - Remote / Telecommute at CYNET SYSTEMS

Regulatory (Expert) - Remote / Telecommute

CYNET SYSTEMS Wilmington, DE (Remote) Full-Time
Job 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 Old 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 authorities requests/inquiries dealing with regulations and product compliance.
Represents company in external bodies dealing with standards and/ product regulations at the national/regional/global level.
May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.

Qualifications:

Bachelor's or Master's Degree or equivalent.
Post-graduate, certification, and license may be required.
Typically, at least 8+ years relevant experience for entry to this level.

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