Regulatory Affairs Specialist

Proclinical are recruiting a Regulatory Affairs Specialist for a medical technology and devices organisation. This role is on a contract basis and is located in Galway with the ability to work on a hybrid basis.

Responsibilities:

• Guide or gathers all resources needed in proposals, license renewal and yearly registrations.
• Supervise and improve tracking/control systems.
• You will suggest changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• The ideal candidate will keep abreast of regulatory processes and changes.
• Might direct interaction with regulatory agencies on outlines matters.
• Responsible for directing or conducting arrangements and preparing of document packages for regulatory proposals from all areas of company, internal audits and inspections.
• Suggest methods for earliest possible approvals of clinical trials applications.
• Other duties may be assigned to this role.

Key Skills and Requirements:

• Works well independently.
• An organised individual.
• Capable of resolving issues.
• Communication skills both verbally and in writing.
• Leadership abilities.
• Know-how and proficiency in job field attained from a combination of education and experience.
• Educated to a degree level with at least 2 years of pertinent work experience or educated to an advanced degree level with no experience necessary.

If you are having difficulty in applying or if you have any questions, please contact Numhom Sudsok at +44 203 8718 093.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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