Medical Devices Regulatory Specialist

16 hours ago

Sligo, Sligo, Ireland beBeeRegulatory Full time

Job Summary:

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  • We are seeking a skilled Medical Devices Regulatory Specialist to join our team.
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About the Role:

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This is an exciting opportunity for a highly motivated and experienced individual to take on a key role in ensuring compliance with regulatory requirements for medical devices. The successful candidate will be responsible for generating documentation that supports global medical device registration and ongoing compliance with EUMDR regulations.

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Main Responsibilities:

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  • Maintain awareness of and ensure compliance with local and global medical device processes, regulations, and guidelines.
  • Develop and implement training programs for individuals involved in medical device activities.
  • Monitor medical device system performance, track compliance metrics, and report to leadership.
  • Ensure audit readiness, support audits/inspections, and lead corrective actions.
  • Contribute to signal detection, evaluation, and prioritization for safety profiles of registered medical devices.
  • Review and provide input on product Design FMEA (Failure Mode and Effects Analysis).
  • Assist in drafting and implementing Safety Data Exchange Agreements.
  • Work cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory reporting guidelines.
  • Prepare and review aggregate safety reports.
  • Responsible for strategic preparation of medical device regulatory submission documentation.
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Requirements:

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  • Bachelor's or Master's degree in a related field or equivalent experience.
  • Minimum 5-7 years of experience in medical device regulatory submissions, with proficiency in Notified Bodies under EUMDR/MedDEV and knowledge of relevant standards and guidelines.
  • Solid understanding of medical device regulatory requirements and process development/compliance.
  • Strong medical knowledge and understanding to support safety-related activities.
  • Knowledge of Vigilance reporting regulations globally.
  • Leadership experience in complex projects or programs desirable.
  • Fluency in spoken/written English; computer proficient.
  • Excellent communication, interpersonal, and organizational skills.
  • Commitment to compliance and scientific quality/integrity.
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Benefits:

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  • Opportunity to work in a dynamic environment with a global influence.
  • Professional growth and development opportunities.
  • Chance to contribute to the success of the organization.
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Career Growth:

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This role offers a unique opportunity for career advancement and professional growth. The ideal candidate will have a strong foundation in medical device regulation, excellent communication skills, and the ability to work effectively in a fast-paced environment.

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Working Environment:

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The company values a diverse and inclusive work environment and is committed to providing equal opportunities to all employees. The successful candidate will be part of a dynamic team that is passionate about delivering high-quality results.

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