Regulatory Affairs Manager
Company: HireResources
Location: Oceanside
Posted on: February 26, 2021
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Job Description:
This position is responsible for implementing and managing the
Companys regulatory affairs function: Oversee and maintain ongoing
relationships with regulatory authorities Responsibilities include
the development, implementation, and management of the Companys
compliance functions Responsible for ensuring general compliance
with Federal and State regulations applicable to the manufacture
and distribution of medical devices, including facility licensure
and product registration Formulates and establishes clear
objectives and work plans; reviews progress against targets and
creates countermeasures, where necessary, to achieve success
Develops RA Strategy and may also be responsible for managing a
team of RA specialists Communications with regulatory bodies on
significant matters, including formal responses to regulators on
submissions, with supervision Communicates regulatory requirements
to functional leaders, exercises judgment on when to escalate
regulatory queries for managerial input KEY RESPONSIBILITIES:
Create and manage domestic and global product submissions (e.g. EU
Technical Files, International Dossiers, 510ks), including CFGs,
Certificates of Free Trade, and legalization of regulatory
documentation Manage internal processes to meet FDA, EU, Health
Canada, Notified Body, and other regulatory authority requirements
Complete regulatory assessments for new products or product
modifications and develop regulatory strategies for their
respective product launches domestically and internationally
Support and provide regulatory guidance on pre-production and
design releases of new product development for domestic and
international distribution Maintain current state and federal
registrations (wholesale distribution) Review and approve labeling
and promotional materials Manage regulatory compliance activities
such as HHEs, adverse event reporting, and recall execution and
reporting Monitor and communicate changes to regulations,
legislation, guidance documents, and policy to determine the impact
on the organization Oversee government inspection activities,
including inspectional observations, as well as corrective action
plans Train and develop direct reports to ensure successful TSM
growth within the organization
Keywords: HireResources, Oceanside , Regulatory Affairs Manager, Executive , Oceanside, California
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