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Contact Info
Kevin Silke
Life Science

01 507 9255
[email protected]
Connect with me on
Quality Engineer
Limerick
Regulatory Affairs Specialist
Republic of Ireland
Program Manager
Westmeath
Risk Manager
Dublin
VP of R&D
Galway
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Details

Regulatory Affairs Specialist


Reference:KG-AVFE-465823 Location: Republic of Ireland
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Would you like to join a successful medical device compny in Ireland to further develop your career? This is an excellent opportunity to work with leading technologies in the medical device industry.

The regulatory affairs specialist helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The regulatory affairs specialist serves as a communication liaison between the manufacturer and the local affiliates or regulatory authorities.

Responsibilities

  • Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO, MDR and FDA.
  • Ensures a thorough understanding of the products they are assigned.
  • Communicates country/region specific regulatory requirements to the regulatory specialists/ managers.
  • Develop global regulatory strategies for medical devices in collaboration with other regulatory affairs or clinical personal, especially on high risk devices.
  • Advise other functional units (engineering, marketing, operations, quality etc) of the requirements in each target market.
  • Ensure the outputs from the individual functional units meet the applicable regulatory requirements.
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
  • Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license.


Qualification

  • Third level Qualification preferably in Science/Engineering.
  • 5 years’ experience in a regulated industry in a similar role desirable.
  • Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.
  • Knowledge of medical device quality standards/practises or similar regulated industry.

If you meet the Qualifications/Requirements, and feel this is a good role for you, please apply today!