What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at Intellectt Inc?
Responsible for compiling and maintaining US 510k submission and EU IVDR Technical File.Responsible for compliance with applicable Corporate and Divisional Policies and proceduresunder the quality system.
Core Job Responsibilities For This Role May Include
Individuals execute and manage technical and scientific regulatory activities for the responsiblecountries/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 variousregulatory 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.
Minimum Education
5 years experience in a regulated industry (e.g.. medical devices, pharmaceuticals).
Core Job Responsibilities For This Role May Include
- Compile, prepare, and review regulatory submission to US and EU.
- Anticipate regulatory obstacles and emerging issues throughout the product submissioncycle 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 tointernal stakeholders
- Monitor and submit applicable reports and ensure appropriate responses are submittedto 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 submissionfiling
- Provide registration impact assessment in responsible countries/region for designchanges
- Provide strategic input and technical guidance on regulatory requirements todevelopment 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 responsiblecountries/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 variousregulatory 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.
Minimum Education
- 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.)
5 years experience in a regulated industry (e.g.. medical devices, pharmaceuticals).
