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Regulatory Affairs Manager

Company: HireResources
Location: Oceanside
Posted on: November 19, 2021

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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