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
Employment Type: Full-Time
Job Tags
Full time,
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