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Global Medical Device Compliance Specialist

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Sligo, Sligo, Ireland beBeeExpertise Full time

Medical Devices Global Regulatory Expert

Job Description

The Medical Devices Global Regulatory Expert will be responsible for ensuring compliance with regulatory requirements for Abbott Nutrition medical devices. The ideal candidate will have a deep understanding of medical devices and experience in generating documentation that supports global medical device registration and on-going compliance with EUMDR.

Responsibilities
  • Organize, manage and maintain a highly compliant global medical device system for Abbott Nutrition products.
  • 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.
  • Monitor medical device system performance; track compliance metrics and report to global leadership team.
  • Ensure global/local medical device audit readiness; Support medical device audits/inspections and lead activities related to corrective and preventative actions for any audit findings.
  • Actively contribute to activities related to the monitoring of safety profiles for Abbott Nutrition products registered as medical devices, such as signal detection, evaluation, and prioritization.
Requirements

To succeed in this role, you will need:

  • A Master's degree in a related health science or equivalent skills, education, or experience.
  • RAC certification is a plus.
  • 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).
  • Solid understanding and working knowledge of medical device regulatory requirements and in the development and implementation of processes to maintain compliance.
  • Strong medical knowledge and understanding to support safety related activities; background/experience with nutrition/nutritional products is a plus.
  • Knowledge of Vigilance reporting regulations on a Global scale.
  • Minimum 3 years of experience in leading complex projects or programs; global/regional experience desirable.
  • Fluency in spoken/written English.
  • Computer proficient (Windows, Word, Excel); experience working in adverse event databases.
  • Excellent communication and interpersonal skills, both written and spoken.
Benefits

As a Medical Devices Global Regulatory Expert, you will enjoy:

  • A dynamic and challenging work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.
About Us

We are a leading healthcare company dedicated to improving lives through innovative medical devices and solutions. Our team is passionate about delivering exceptional results and making a meaningful impact in the lives of our customers and patients.