Leading Medical Device Regulatory Compliance Specialist

2 days ago

Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €80,000

Job Title:

Regulatory Affairs Specialist

This is a key role within our organization, requiring a strong understanding of medical device regulatory requirements and industry standard practices.

  • Responsibilities will include managing day-to-day regulatory activities, handling multiple projects related to product and compliance enhancements, and working closely with the QA Manager for notified body audits and other audits as required.
  • Key responsibilities also include assisting in the migration from MDD to MDR within the organization, supporting the wider team to ensure product manufacture and testing meets the requirements of both CE mark and FDA submissions.
  • Work with suppliers to ensure products' process validations and risk management files are to the standard of regulatory submissions.
  • Provide strategic regulatory insight to team members regarding product development plans, work with the Commercial Team/Distributors to ensure country-specific registration activities are understood and appropriately addressed.
  • Maintain with the QA Manager the day-to-day activities of Post Market Surveillance, including logging customer complaints and adverse events, coordinating investigations between complainants and contract manufacturing sites, and addressing initiatives to test, change, and improve products as required.

Requirements:

  • Bachelor's degree in engineering or science with a minimum of 4 years of experience in a medical device company.
  • Regulatory certifications in MDR desirable.
  • A minimum of 4 years of experience in the medical device industry.
  • Thorough understanding and knowledge of ISO 13485 and, ISO 14971, MDD & MDR. Proven track record with the ability to successfully manage projects to deadlines.
  • Experience working directly with regulatory agencies.
  • Strong ability to manage critical projects as part of an interdisciplinary team.
  • Excellent problem-solving and communication skills.
  • Must be self-motivated, highly organized, and detail-oriented.
  • Excellent oral and written communication skills.
  • Must be able to work as part of a cross-functional team.
  • Thrives to work in a fast-paced/entrepreneurial environment.

Location: Cork

Country Code: IE

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