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Regulatory Affairs Lead

  • Location:

    Galway

  • Contact email:

    jporter@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    091 455305

  • Job type:

    Full Time

  • Job ref:

    JPREGAFFLEREGy

  • Salary:

    Negotiable

  • Published:

    about 1 month ago

  • Contact email:

    jporter@sigmar.ie

  • Consultant:

    James Porter

Job description

Regulatory Affairs Lead

Fast paced multinational medical device company whose Galway site primarily specialise in the design and manufacturing of guidewires. They have a fantastic flexitime policy with a fast-paced manufacturing environment which will give employees plenty of opportunities to progress and gain lots of experience as they grow.

Responsibilities: 

  • Provide leadership for the site on any device design change.
  • Complete submissions for CE Marking Registration, 510(k) registration and PMAs.
  • Oversee the completion on technical dossiers, regulatory annual reports, supplements and registrations.
  • Lead the regulatory preparation for the site for FDA, ISO13485, Customer and Corporate audits.
  • Advise on certain customer complaints and investigations.
  • Support queries coming from other sites or notified bodies.
  • Answer customer regulatory requests and complaints.
  • Support validation documentation programs.
  • Review technical files for compliance to relevant medical device requirements.
  • You will supervise the development of the QMS and change control process ensuring compliance to 21 CFR 820, MDR, MDD, ISO13485 and ISO14971

 Requirements: 

  • Level 8 degree in engineering, science or relevant field.
  • Must have 4 years previous experience in regulatory affairs.

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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