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,
Similar Jobs
Vetegrity
...SharePoint Developer **This position is contingent upon contract award** An active TS/SCI with a polygraph clearance is required to be considered for this position. Position Overview: Exposure to and experience with SharePoint Server required. Back-end SharePoint...
Gpac
...and financially strong General Contractor with a steady project pipeline and a focus on quality, safety, and long-term success.... ... 5+ years of experience as a Superintendent on commercial construction projects Proven success managing ground-up or remodel jobs...
Fiserv
...Calling all innovators find your future at Fiserv. Were Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations, merchants, and consumers to one another millions...
SWA Group
...collaborative team Requirements: ~ A professional undergraduate or graduate degree from an accredited program in landscape architecture. The ideal candidate has: ~1-3 years professional experience in a design office ~ Strong design skills ~...
Stellent IT LLC
...Job Description Business Analyst- SOX & SOC Chicago, IL 6+ Months Musts: IT Controls - Develop and maintain controls Writing IT controls to business processes validate controls Mid level 5 years Experience with any compliance...