Category
Location
Type

Health & Safety

Quality & Regulatory Officer

Posted on:

Monday 13th June 2022

Overview of role:

Description:

We are currently recruiting for a Quality & Regulatory Officer for our client in the medical devices industry based in Dublin 18. The Quality & Regulatory Officer is responsible for carrying out regulatory and pharmacovigilance activities in accordance with Good Pharmacovigilance Practices, relevant EU regulation and company Quality Management Systems.

Duties & Responsibilities:

  • Provide support to our Distribution partners with their Regulatory Requirements
  • Ensure that all new licence and variation applications are reviewed, planned, tracked and obtained in a timely manner in accordance with EU submissions procedures
  • Ensure prompt responses to all requests for information from the various regulatory authorities
  • To review and approve marketing and advertising materials and activities in accordance with The Medicinal Products (Control of Advertising) Regulations, 2007 (S.I. No. 541 of 2007) and relevant Codes of Practice
  • Provision of regulatory information, support and advice
  • Provide support to internal and external customers
  • Assist in the training of company personnel
  • Provide technical support to department members and peers in other departments as required
  • Ensure all relevant SOPs reflect current practices and update as appropriate. Compile additional SOPs as appropriate
  • Attend external meetings/training courses to maintain/improve regulatory knowledge
  • Provide support to our Distribution partners with their Pharmacovigilance Requirements

Support Pharmacovigilance activities including:

  • Ensure compliance with Volume 9A of The Rules Governing Medicinal Products in the EU and GVP modules, Reg 1235/2010, Reg 520/2012 and directive 2010/84/EU as applicable, and also the company procedures
  • Ensure that information about all relevant suspected adverse reactions reported to the company and affiliates as defined in agreements, is collected, collated and is accessible within the electronic system
  • Tracking, completion of review of local scientific literature and ensure relevant information for reporting to Competent Authorities is reported to MAH in a timely manner
  • Reviewing of PV agreements and SDEAs from Distribution partners
  • Ensure identified safety variations are planned, tracked and sent as per set timelines in accordance with the legislation
  • Respond to queries from regulatory authorities

 

Quality

  • To assist in Medical Device Regulatory Activities including technical file review and building and responsibilities incl. vigilance for company products and assist other sites when required
  • Support the management of the Quality Management Systems and maintenance of GMP, GDP, authorisations and ISO certifications for all sites including CAPA management, Issues management (Recalls, Complaints, and Vigilance), SOP writing and approving, change control, coordination and completion of audits, validation, quality risk management, KPIs tracking and reporting and support the management of the eQMS system
  • 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

Requirements:

  • Relevant Third Level qualification
  • Auditor Certified (e.g. ISO 9001 and/or ISO 13485 or pharma equivalent)
  • 3-5 years’ experience of PV/Reg and ISO systems
  • Familiarity of good pharmacovigilance practices (GVP)
  • Knowledge of medical and drug terminology
  • Flexibility to travel and ability to audit effectively in a multinational environment as the need arises
  • Proven problem-solving ability
  • Strong oral and written communication skills
  • Strong interpersonal and leadership skills

Desirable Qualifications:

  • 3-5 years’ experience in Regulatory, Medical information or Pharmacovigilance role
  • Experience of regulatory body liaison e.g. HPRA, MHRA
  • QMS software systems experience
  • Familiarity with Irish H&S and Environmental Legislation and regulations desirable
  • Health & Safety qualifications e.g. Manual Handling Certified, VDU Assessor

This is a full-time, permanent role with a salary of €40K – €45K, plus bonus and pension.

Salary:
See description

Closing date:
31/07/2022

Reference number:
DL/VM25