Regulatory Reporting Specialist

1 week ago

Galway, Galway, Ireland beBeeRegulatory Full time €50,400 - €57,400
Job Title: Regulatory Reporting Specialist

Key Responsibilities:

  1. Monitor the company's drug or medical devices surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports.
  2. Participate in resolving legal liability and ensure compliance with government regulations.
  3. Maintain accurate records of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, and adverse reaction data as required by regulatory agencies.
  4. Review and analyze clinical databases for ADE data extraction and integrate the data to create a unified database.
  5. Support ADE standardization and internalization for safety summaries accuracy and quality.
  6. Act as an internal liaison and collaborate externally to develop programs and processes for regulatory reporting.
  7. Deliver and manage assigned projects, working with stakeholders for desired results.
  8. May mentor colleagues or direct lower-level professionals.
  9. Focus on delivering and overseeing projects from design to implementation while adhering to policies and utilizing specialized knowledge.

Requirements:

  1. Entry-level professional with responsibility in a professional discipline or specialty.
  2. Works under close supervision.
  3. Delivers work of limited scope on smaller and less complex projects.
  4. Identifies and addresses problems typically not difficult or complex; makes minor changes to systems and processes.
  5. Communicates primarily with internal contacts within the immediate group to gather, confirm, and convey information.
  6. Focuses on self-development without leadership or talent management responsibilities at this level.
  7. Requires broad theoretical job knowledge typically obtained through advanced education.

What You'll Gain:

  • Opportunity to develop skills in regulatory reporting and compliance.
  • Chance to work on complex projects and contribute to the company's growth.
  • Collaborative environment with experienced professionals.
  • Professional growth and development opportunities.

About Us:

We are a leading organization in the industry, committed to excellence and innovation. We strive to provide our employees with challenging roles and opportunities for growth and development.

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