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Details

Regulatory Affairs Specialist


Reference:/RH/ASNW-680211 Location: Republic of Ireland
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Specialist

Life Science Recruitment is hiring for a Regulatory Affairs Specialist to join our clients expanding Life Sciences division. This is a hybrid role, the successful candidates will be responsible for managing Quality Systems, Regulatory Compliance, and support Quality Engineering activities for our clients and work for a variety of products and technologies to ensure compliance with medical device standards and regulations, including: 21 CFR Part 820, ISO 13485, MDD, AIMD, MDR and CMDCAS.


Responsibilities:

  • Be a Regulatory Affairs subject matter expert for our clients, providing guidance and expertise
  • Support development, collation, and review of data for US FDA, EU MDD/MDR regulatory submissions to Notified Bodies for Class I to III design dossiers and tech files
  • Work with various functional teams within client companies to ensure device compliance to appropriate regulatory requirements
  • Keep up to date with new or revised medical device regulations and standards to ensure continuous compliance for client projects
  • Assess changes to products and documents with respect to relevant regulatory requirements
  • Communicate with regulatory authorities for clients
  • Support CAPA investigations
  • Support Complaint investigations and report adverse events to the relevant notified bodies
  • Support regulatory gap analysis assessments
  • Assist clients with preparation and activities for Notified body and Internal audits

Qualifications and Experience:
  • Graduate with Engineering or Science degree, or equivalent experience
  • Qualified systems lead auditor and MDD/MDR compliance is preferred.
  • Minimum 2 years’ experience in a regulatory affairs role in the pharmaceutical, healthcare or medical device sector essential.
Skills:
  • Excellent client-facing skills
  • People management skills - introducing and building ways in which people can learn from each other, encouraging mentoring and the transfer of knowledge by designing and delivering learning interventions
  • Team work and emotional intelligence
  • Good self-management – continuous performance is both an objective and a mind-set
  • Has an innovative approach – a bold thinker and doer, matching creativity with vigilance
  • High value on openness and transparency
  • Strong interpersonal and communications skills,and fluent in English, both in writing and speaking
  • Good technical report writing skills
Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required.
No visa sponsorship will be offered with this role.

Call Ruth Holland on 087 7822 198 for more details.