Global Regulatory Affairs Specialist in Framingham, MA US at Apex Systems
Company: Apex Systems Inc.
Location: Framingham
Posted on: April 6, 2021
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Job Description:
Global Regulatory Affairs Specialist in Framingham, MA US at
Apex Systems Interacts with RA colleagues world-wide; Coordinates
and prepares regulatory document packages to support pre- and
post-market changes; Provides project team representation, consults
on regulatory project needs and is responsible for coordinating and
reviewing required regulatory documentation/submissions. Provides
direction in managing information from/to other departments.
Monitors and tracks information, ensuring accurate communication of
the current status of post-approval change control assessments and
submissions; Reviews technical documentation; Recommends/approves
changes for manufacturing and compliance, ensuring conformance with
existing regulatory approvals; Responsible for determining if
changes and deviations are in compliance with regulatory licenses
(in all applicable countries). Qualifications
Keywords: Apex Systems Inc., Framingham , Global Regulatory Affairs Specialist in Framingham, MA US at Apex Systems, Other , Framingham, Massachusetts
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