Job Description

• 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.

• 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.

Job Tags

Similar Jobs