Quality and Compliance Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €40,000 - €50,000
Job Description

The Quality and Regulatory Specialist plays a pivotal role within the quality control and regulatory affairs team, supporting matters related to quality, regulatory compliance, and risk management.

Key Responsibilities:
  • Identify and manage regulatory requirements under Medical Device Regulation (MDR), ensuring adherence to contractual and regulatory obligations.
  • Review and approve regulatory documentation for new vendors and product setups, verifying accuracy and consistency.
  • Monitor and record product classifications, identifying registration or licensing requirements, and maintaining accurate records.
  • Oversee and manage queries from Suppliers, Customers, internal stakeholders, and regulatory authorities, providing timely and effective responses.
  • Contribute to the preparation of Key Performance Indicator (KPI) reports for the team, analyzing metrics and making recommendations for improvement.
  • Provide administrative support as needed, including data entry and document management tasks.
  • Assist in conducting internal audits and preparing for external audits, ensuring compliance with regulatory standards.
Required Skills and Qualifications
  • Experience in Regulatory Affairs within Medical Devices/Pharma Distribution, with a strong understanding of regulatory frameworks and industry standards.
  • Excellent communication, interpersonal, and prioritization skills, with the ability to work effectively in a team environment.
  • Strong analytical and problem-solving skills, with the ability to interpret complex data and make informed decisions.
  • Proficiency in query management technology platforms, with experience in data analysis and reporting.
  • Attention to detail and commitment to continuous improvement, with a focus on quality and customer satisfaction.
Benefits

This role offers a competitive salary and benefits package, including opportunities for professional development and growth. The company operates a flexible working model, allowing for a balance between face-to-face interactions and virtual working. We strive to create a supportive environment that understands the interplay between work and life.

Our Culture and Work Environment

We operate under Our Medtech Mindset, which guides our culture and work environment. This includes:

  • Embracing collaboration and progress over perfection.
  • Prioritizing compliance and risk management for exceptional outcomes.
  • Focusing on quality, customer satisfaction, and commercial success.

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