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Quality, Regulatory Officer

Req ID:  4445
Company:  DCC Vital - Fannin Ltd
Salary:  DOE
Location: 

Leopardstown, IE, Dublin 18

Contract Type:  Permanent
Date Posted:  14-Jul-2022
Description: 

Location: Fannin House, Dublin 18, Ireland

Department: Qual          Job Title - Quality & Regulatory Officer 

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Summary

The Quality & Regulatory Officer is primarily responsible for carrying out Quality and Regulatory activities in accordance with Medical Device Regulation and company Quality Management Systems

 

Principal Duties and Responsibilities

 

Medical Device Activities

  • Efficient management of Regulatory Technical files to maintain CE Marking for Fannin Group and support for other sites.
  • Coordination of Medical Device Regulatory Activities and Responsibilities incl. vigilance for Fannin Ltd, Fannin (NI) Ltd, and support other sites.
  • Regulatory Support for Medical Divisions and implementation of Regulatory Requirements.
  • Post Market Surveillance of Fannin Products
  • Implementation of Non EU suppliers review system for distribution by Fannin
  • To schedule and carry out internal and external audits for Fannin and coordinated the audits with other DCC Vital site personnel.
  • To coordinate the Regulatory Intelligence for Medical Devices activities, sharing relevant information to other sites.
  • To Manage Risk Assessments of products, suppliers & Services

 

Quality

  • Support the Quality, Regulatory and Environmental, Health & Safety (QREHS) Management Systems and maintenance of certifications for Fannin sites, through activities such as:
  • Auditing
  • Creation/review of SOPs
  • Change control
  • Complaints/vigilance/recalls,
  • Facilitation of CAPA process
  • Super-user for QMS software
  • Preparation and submission of data for monthly, quarterly and annual reports (KPIs)
  • Support to requirements such as GDP, GMP, Tissues, Regulatory, Compliance, LSAS (Labour Standards) and SCIP (Supply Chain Integrity Process).
  • Support of Sales & Marketing in following areas:
  • Tenders submissions
  • Promotional materials
  • Training materials and delivery of same
  • Business development support as advised by Divisional Directors
  • Delivery of relevant training requirements such as Quality, Regulatory, EHS, Good Distribution Practice (GDP)
  • Assist the development of the business by working with the relevant departments to assist them in achieving the required licensing and certification standards
  • Support and cover for the team
  • Manage and maintain good professional working relationships both internally and externally
  • Maintain the company’s philosophy and management
  • Facilitate and support the maintenance of the Environmental, Health & Safety System management
  • Other activities as required by the role

 

Requirements:

  • Relevant Third Level qualification
  • 3-5 years experience Medical Device Regulatory Environment
  • Experience in GMP, GDP and ISO environments
  • Experience of regulatory body liaison e.g. the HPRA, MHRA
  • Flexibility to travel and ability to audit effectively in a multinational outage environment as the need arises

 

Desirable Qualifications:

  • Working knowledge of ISO13485, 9001)
  • Auditor Certified (e.g. ISO9001 and/or ISO13485 or pharma equivalent)
  • Knowledge of Irish H&S and Environmental Legislation and regulations desirable
  • QMS software systems experience

 

Desired Characteristics:

  • Pro-active
  • Flexible and adaptable to changing environment
  • Ability to interface effectively with all levels within the company as well as organizations outside Fannin (regulatory agencies)
  • Proven problem solving and trouble shooting skills
  • Strong oral and written communication skills
  • Strong interpersonal and leadership skills

 

Other Information:

Please note that all DCC Vital staff work within a quality management system and that all of the above will apply to the full DCC Vital product portfolio which includes products such as medical devices, pharmaceuticals and tissues.

 

 

 

 

 

- DCC Vital IS AN EQUAL OPPORTUNITY EMPLOYER -

 

Although the above is a description of the requirements of your job, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.