Strategic Regulatory Specialist

1 week ago


Cork, Cork, Ireland beBeeCompliance Full time €80,000 - €110,000

Regulatory Affairs Associate Role Overview

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This is an exciting opportunity to develop your experience and career in the medical device industry.

As a key member of our regulatory team, you will be responsible for driving global regulatory submissions, ensuring compliance with standards and regulations, and maintaining our company's reputation as a trusted partner.

Key Responsibilities Include:

  1. Supporting day-to-day regulatory activities and handling multiple projects related to regulatory compliance enhancements.
  2. Implementing MDSAP within the organization to ensure effective regulatory practices.
  3. Working closely with the commercial team and distributors to ensure country-specific registration activities are understood and appropriately addressed.
  4. Collaborating with interdisciplinary team members to ensure the effectiveness of our quality management system (QMS) and meeting regulatory requirements.
  5. Supporting internal and external audits, including notified body audits, to maintain our company's compliance and reputation.
  6. Working with the organization's suppliers to ensure products meet regulatory requirements and comply with CE mark and FDA submissions.
  7. Providing strategic regulatory insight to team members regarding product development plans and post-market surveillance activities.
  8. Maintaining daily post-market surveillance activities, including risk management files and process validations.


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