Regulatory Compliance Specialist

2 weeks ago

Sligo, Sligo, Ireland beBeeCompliance Full time €85,450 - €105,320
Medical Device Regulatory Manager">

This role involves organizing, managing and maintaining a highly compliant global medical device system for our client. The ideal candidate will have in-depth knowledge of medical devices and the ability to ensure compliance with regulatory requirements.

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  • ">
  • Maintain awareness and ensure compliance with established and updated local and global medical device processes as well as local and global regulations and guidelines for medical device registration and post-market documentation.">
  • Develop and implement training programs for individuals involved in medical device activities.">
  • Monitors medical device system performance; tracks compliance metrics and reports to global leadership.">
  • Ensure global/local medical device audit readiness; Supports medical device audits/inspections and leads activities related to corrective and preventative actions for any audit findings.">
  • Actively contributes to activities related to the monitoring of safety profiles for registered products, such as signal detection, evaluation, and prioritization.">
  • Reviews and provides input to product development files.">
  • Assists with drafting and implementation of Safety Data Exchange Agreements, if applicable.">
  • Works cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures.">
  • Assists in the preparation, review and submission of aggregate safety reports.">
">Key Requirements:">

Education: Master's degree in a related health science or equivalent skills, education, or experience.

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Skills and Qualifications: 5-7 years of experience and proficiency in medical device regulatory submissions to Notified Bodies under EUMDR / MedDEV and knowledge of Medical Device standards and guidelines (such as ISO, GSPR, and MDGC).

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Benefits:

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  • ">
  • A competitive salary package including bonuses.">
  • An excellent benefits package including health insurance, pension scheme, and annual leave.">
  • Opportunities for professional growth and development.">
  • A dynamic and supportive work environment.">
">About Us:">

We are a leading healthcare company committed to improving lives through innovative medical devices and solutions. Our team is passionate about delivering exceptional results and making a positive impact on people's lives.

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Contact us today to learn more about this exciting opportunity

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