Regulatory Compliance Professional

2 weeks ago

Cork, Cork, Ireland beBeeRegulatoryAffairs Full time €60,000 - €80,000
Regulatory Affairs Specialist

We are seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of the Clinical and Regulatory Affairs department, you will play a crucial role in ensuring compliance with regulatory standards and submitting necessary documents to relevant authorities.

Your primary responsibility will be to ensure that our products meet all required regulatory standards and submit applications for CE mark and FDA clearance. You will work closely with the QA Manager to maintain a high level of quality assurance within the company and ensure that all regulatory submissions are completed accurately and on time.

  • Collaborate with the QA Manager to develop and implement effective quality management systems that meet regulatory requirements.
  • Manage day-to-day regulatory activities, including product development, clinical trials, and market authorization submissions.
  • Work closely with the Commercial Team/Distributors to ensure country-specific registration activities are understood and addressed.
  • Maintain post-market surveillance activities, including logging customer complaints and adverse events, and coordinating investigations between complainants and contract manufacturing sites.
  • Evaluate manufacturing and labeling changes, as well as promotional materials, for regulatory impact and to ensure compliance with applicable regulations.
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.

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