Senior Regulatory Compliance Expert

1 day ago

Cork, Cork, Ireland beBeeRegulatory Full time €86,130 - €103,456
Regulatory Affairs Specialist Job

We are seeking a skilled Regulatory Affairs Specialist to ensure compliance with regulatory standards and manage day-to-day regulatory activities.

About the Role

This role involves working closely with the QA Manager to ensure the effectiveness of the QMS to regulations, managing day-to-day regulatory activities, and handling multiple projects related to product and compliance enhancements.

Main Responsibilities
  • Ensure compliance with regulatory standards and maintain effective Quality Management Systems (QMS).
  • Work closely with the QA Manager to ensure notified body audits and other audits are handled efficiently.
  • Manage multiple projects related to product and compliance enhancements.
  • Migrate from MDD to MDR within the organisation.
  • Support the team in ensuring product manufacture and testing meets the requirements of CE mark and FDA submissions.
  • Work with suppliers to ensure products' process validations and risk management files are compliant with 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 addressed.
  • Log customer complaints and adverse events, coordinate investigations between complainants and contract manufacturing sites, and address initiatives to test, change and improve the products as required.
  • Monitor global regulatory trends and requirements impacting the development and commercialization of products.
  • Evaluate manufacturing and labelling changes, and promotional materials for regulatory impact.
  • Maintain awareness of global regulatory legislation and assess its impact on business and product development programs.
  • Keep abreast of changes in domestic and international regulations and guidelines.
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, 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.
  • Self-motivated, highly organised, and detail-oriented.
  • Excellent oral and written communication skills.

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