Medical Device Regulatory Affairs Specialist

2 weeks ago

Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €80,000
">Regulatory Affairs Specialist">

Job Description:

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We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will be responsible for ensuring compliance with all relevant regulations and standards.

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  • ">
  • Develop and execute regulatory strategies for product registration, approval, and compliance.">
  • Manage day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements.">
  • Management of regulatory submissions, including the preparation, maintenance, review, and submission of regulatory documents and applications to health authorities.">
  • Support the team in obtaining or retaining country-specific regulatory registrations on a global basis.">
  • Manage the implementation of MDSAP within the organization.">
  • Monitor and ensure compliance with national and international regulatory requirements and quality standards.">
  • Identify and assess potential regulatory risks and propose/implement effective mitigation strategies.">
  • Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes.">
  • Stay current with changing regulations, guidelines, and industry trends.">
  • Contribute to maintaining the highest level of quality within the organization by assessing overall risk profiles and creating programs/tools to mitigate potential risks.">
  • Maintain 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.">
">Required Skills and Qualifications:">
  • ">
  • Bachelor's degree in Engineering or Science with a minimum of 6 years of regulatory experience in the medical device industry.">
  • Regulatory certifications in EU MDR and US FDA desirable.">
  • Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, 21 CFR 820, and supporting standards.">
  • 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.">
">Benefits:">
  • ">
  • Competitive salary.">
  • Bonus.">
  • Pension.">
  • Healthcare.">
  • Excellent opportunity to develop your experience and career in an exciting company.">
">

This is a unique opportunity to be at the forefront of innovation and make a significant contribution to the company's success. If you are an enthusiastic self-starter with a willingness to be a

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