Regulatory Affairs Expert

2 days ago

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

Job Summary

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We are seeking an experienced Regulatory Affairs Professional to join our team. In this role, you will be responsible for regulatory submissions worldwide, annual reporting to notified bodies and competent authorities, and maintaining compliance to standards and regulations.

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  • You will support day-to-day regulatory activities, handle multiple projects related to regulatory compliance enhancements, and assist in the implementation of MDSAP within the organization.
  • You will work closely with interdisciplinary team members to ensure the effectiveness of the Quality Management System (QMS) to regulations.
  • You will support the team to obtain/retain country-specific regulatory registrations on a global basis.
  • You will work with the Commercial Team/Distributors to ensure country-specific registration activities are understood and addressed.
  • You will monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance.
  • You will evaluate manufacturing and labeling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations.
  • You will maintain awareness of global regulatory legislation and assess its impact on business and product development programs.
  • You will keep abreast of changes in domestic and international regulations and guidelines and advise key staff of compliance/non-compliance with current international regulations, policies, and EC directives.
  • You will support the team with CE mark submissions, significant change notifications, and Notified Body interactions.
  • You will support the team with the preparation of international regulatory filings, including 510(k) submissions and subsequent FDA correspondence.
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