Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Compile, prepare, and review regulatory submission to US and EU.
Anticipate regulatory obstacles and emerging issues throughout the product submission cycle and develop solutions with other members of regulatory and related teams.
Provide regulatory input for responsible countries/region for product lifecycle planning.
Monitor applications under regulatory review and communicate application progress to internal stakeholders.
Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
Utilize technical regulatory skills to propose strategies on complex issues.
Identify emerging issues for responsible countries/region.
Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
Provide registration impact assessment in responsible countries/region for design changes.
Provide strategic input and technical guidance on regulatory requirements to development teams.
Ensure external communications for regulatory purposes meet regulations.
Individual provides leadership without direct authority (i.e., project leader).
Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments.
Individuals execute and manage technical and scientific regulatory activities for the responsible countries/region. Must function independently on regulatory submissions with minimal oversight from management; and must assure that deadlines are met.
Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.
Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments.
Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs.
Requirements:
Bachelor’s Degree in Science (Biology; Chemistry; Microbiology; Immunology; Medical Technology; Pharmacy; Pharmacology); Math; Engineering; or Medical fields is preferred.
M.S. in a technical area is helpful.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
8 years experience in a regulated industry (e.g. medical devices, pharmaceuticals).
Individuals with "hands-on /authoring experience with US 510k submission or EU MDR/IVDR technical files.
Individuals with practical experience working with in vitro diagnostics medical devices.
Practical experience in leading cross-functional team on regulatory and compliance related projects.