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Senior Regulatory Affairs Manager

  • Type Permanent
  • Location Dublin, Republic of Ireland
  • Sectors Medical Devices

I am currently working with a leading medical device company who have an immediate opening for a Senior Regulatory Affairs Manager.They are global leaders in the development of innovative formulations and devices for inhaled medical products.

This is a permanent position that offers a great package with 1-2 days remote working.

What will I be doing as a Senior Regulatory Affairs Manager?

  • We are looking for an individual with Regulatory Affairs experience within the medical device industry to work from our luxury new office located in Dublin.
  • As PRRC for the Authorized Representative you will ensure that requirements of the MDD and MDR are fulfilled.
  • Responsible for the communications and interactions with the Competent Authorities in relation to the Authorized Representative duties.
  • You will contribute to Regulatory Affairs medical device activities across the company, ensuring successful and timely approval of all relevant medical device regulatory submissions, ensure global regulatory compliance and to ensure delivery on corporate goals.
  • Provide guidance on regulatory medical device development activities and new product evaluations.
  • To ensure successful collaboration between regulatory, clinical, quality assurance and device engineering to support the business.

What I need to be a Senior Regulatory Affairs Manager?

  • Experience in medical device regulatory affairs including time spent in Industry and/or in a regulatory agency/notified body with demonstrated understanding of and ability to interpret regulations and guidelines governing medical devices, including CFRs, MDD, ISO 13485, EN 60601-1, EN 14971, EU MDR.
  • In-depth understanding of the required medical device regulatory guidelines and standards in conjunction with drug delivery
  • Possess the requisite expertise regarding the regulatory requirements for medical devices in the European Union demonstrated by a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned in, engineering or another relevant scientific discipline,
  • Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
  • Experience with Regulatory Authorities including FDA and Notified Body.
  • Ability to work independently and complete multiple assignments on time Knowledge and/or experience in International registrations and clinical studies is a plus.

If you think the position in Dublin is the step in the right direction for you and have experience in a similar role, don't hesitate in applying. If you think you might be interested in the role and are looking for more information, I will contact you upon application and discuss this further with you!

Please note sponsorship is not offered with this role.

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 Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales