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Regulatory Affairs Specialist

Role: Regulatory Affairs Specialist

Location: Galway

Rate: DOE

Duties and responsibilities include:

  • As appropriate, support compilation of CE mark Submissions / Significant Changes for submission to the Notified Body.
  • Support preparation and maintenance of Technical Files and Design Dossiers.
  • Execution of international registrations.
  • Involvement in the preparation and maintenance of internal procedures to ensure compliance to regulatory requirements.
  • Work with the Commercial Team and Natus Distributors, to ensure country specific registration activities are understood and appropriately addressed.
  • In conjunction with the Regulatory Affairs Manager and in a timely manner; identify and initiate required action(s) to address any adverse trends or regulatory compliance issues.
  • Interact with manufacturing, engineering, R&D and quality representatives on regulatory issues.
  • Support Regulatory body audits, such as FDA, Notified Bodies, Competent Authorities and other global regulatory agencies.
  • Demonstrate and actively promote highest level of professional regulatory discipline.
  • Support vigilance on regulatory data for a range of medical devices
  • Any other duties as required by your supervisor or manager

Qualifications and skills required:

  • Certificate from college or university in an engineering or scientific discipline (Electronics, Mechanical or Chemistry Sciences, Physics or related) with 6 months minimum years related experience and/or training; or equivalent combination of education and experience.
  • Possess a good working knowledge of regulatory expectations and industry practices including industry standards QSR, ISO13485, MDD, MDR, CMDR, JPAL.
  • Excellent organizational; problem solving; decision making; communication (oral and written); and influencing skills.
  • The person must be a "self-starter" in terms of time and task management and be able to operate with minimal supervision.
  • Work experiences in a medical device company are advantageous.

If you are interested in this role or would like to know more please send me your CV for immediate review or if you would like more information please feel free to give me a call.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales