Compliance Manager

1 day ago

Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €120,000

Quality assurance is a fundamental aspect of our operations, and we are seeking an experienced professional to oversee the development and implementation of quality management systems across our medical devices schemes. The successful candidate will be responsible for managing external audits, communicating with regulatory authorities, and ensuring compliance with relevant standards.

Key Responsibilities
  • Manage and maintain quality management systems to ensure alignment with global processes and accreditation requirements.
  • Supervise the implementation of quality-related procedures and documentation, including the Quality Manual, Non-Conformity and CAPA handling, audits and inspections, document and records control, internal audits, quality management reviews, concessions, and impartiality.
  • Lead internal and external audits, and ensure timely closure of CAPAs.
  • Conduct annual quality management reviews and ensure timely follow-up and closure of actions.
  • Compile and analyze data for management review reporting.
Requirements
  • Strong knowledge of Medical Device Regulations (MDD, MDR, IVDR) and ISO 13485, ISO 17021 and MDSAP.
  • 5+ years' experience in Quality Assurance or Regulatory assurance on a global or multi-site scale gained in a Notified Body organization.
  • 2+ year experience in team management.
  • Has at least 10 years' experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories or Industry.
  • Higher education qualification (Masters / Ph.D. / B.Sc. (Hons) Degree) in a relevant life / natural sciences subject.
  • Completed Medical device training on MDD, MDR, IVDR, UKCA, MDSAP and ISO 13485.

Our ideal candidate will have excellent interpersonal and communication skills, negotiation and persuasion skills, change management skills, and strong organizational skills. They will also have a keen eye for detail and operate ethically with the highest degree of professional integrity.

Benefits
  • A dynamic work environment in a leading global company.
  • An open corporate culture with opportunities for personal growth and development.
  • The possibility of remote work and flexible schedules.
  • Access to continuous learning opportunities through SGS University and Campus.

We believe that innovation, collaboration, and continuous improvement are essential for success. If you are passionate about quality assurance and are looking for a challenging role in a multinational environment, please apply to join our team.

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