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Senior Regulatory Affairs Specialist

3 months ago

Princeton, United States Select Source International Full time
Job DescriptionJob Description

Job Title: Senior Regulatory Affairs Specialist

Location: - Princeton, NJ 08540

Duration: - 12 Month contract with possible extension based on performance

  • As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to combine knowledge of scientific, regulatory, and business issues to enable i-STAT branded products that are developed, manufactured, or distributed by Client’s Point of Care to meet required legislation in the US and EU.
  • The individual has site/divisional level influence and is generally recognized as an expert resource of the international regulations within the division for the responsible countries/regions. The individual may represent the department in cross-functionally project supporting product launches, market expansions, or compliance projects. The individual has ownership in analyzing regulatory requirements, identifying data needed, obtain these data using available resources, and ensure that data are effectively organized and presented for the registration of products in the US/EU. The individual is expected to work on-site at the APOC Princeton location 5 days/week from 8:30am - 5pm.

Core job responsibilities:

  • Responsible for compiling and maintaining US 510k submission and EU IVDR Technical File.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures under the quality system.
  • 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

Supervisory / management responsibilities:

  • 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.

Position accountability / scope:

  • 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.

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.)

Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.