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Details

Regulatory Scientist


Reference:JCA021106 Location: Westmeath
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs

Regulatory Scientist



Our client a medical device multinational currently seeks a Regulatory Scientist to join their team. The Regulatory Scientist will develop and manage a variety of reports involving clinical data analyses and review, collaborate and provide clinical research support to cross-functional product development teams and other functions, as necessary.


Role/Responsibilities:

• Develop and manage Post-Market Surveillance Plans (PMSPs), Clinical Evaluation Reports (CERs), Literature Reviews, Clinical Risk Benefit Analyses (CRBAs) and Summary of Safety and Clinical Performances (SSCPs).

• Review and support the development of Post-Market Surveillance Reports (PMSRs), Periodic Safety Update Reports (PSURs), Instructions for Use (IFUs), Hazard Analyses (HAs) and other documents, as needed.

• Develop and manage clinical evidence database, including unpublished reports, publications, and conference communications in support to clinical evidence generation activities and post-market surveillance.

• Provide clinical research support to project teams, risk analysis teams, and other functions.

• Provide support to regulatory specialists for submissions or communications with regulatory agencies or notified bodies.

• Collaborate in pre-market and post-market clinical study activities, including planning, strategy, execution, data analysis, and reporting where necessary.

• Develop, review and maintain clinical research procedures, ensuring compliance with quality system and external regulations and guidelines.



Skills/Experience:

• Bachelor’s degree in biomedical engineering, biological sciences, nursing or other closely related discipline required.

• Minimum of three years’ relevant experience in a medical device background, specifically in clinical and/or regulatory

• Understanding of medical device safety, risk management practices and adverse effects.

• Excellent written communication and demonstrated medical writing and research methodology skills.

• Strong verbal and interpersonal skills.

• Understanding of clinical study management.

• Self-driven with an extremely detail-oriented work s.

• Ability to organize, manage and complete multiple projects.

• Proficiency in Microsoft Office Suite.

• Minimum of 2 years clinical evaluation reporting (CERs) experience preferrable



For further information please contact James Cassidy [email protected] or call in confidence 0860204322