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Vacancy Details


Regulatory Affairs Specialist - Galway - 104060

Location: Galway
Date: 17/05/2019
Job Reference: 104060
Contact Name: Bimi Felix
Contact Email:

Job Description

Regulatory Affairs Specialist - Galway - 104060
Quality Assurance Manager

Our client, a medical device company in Galway is currently looking to recruit a Quality Assurance Manager for their site.

Job Purpose
Fulfil the company’s quality assurance responsibilities, including:
  • Providing management support and leadership for Quality/Regulatory personnel and providing technical support for the manufacture of existing products and the design and development of new products
  • Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality
  • Understanding and complying to company quality, business, health & safety systems and market/legal regulations and associated Regulatory Standards
  • Removing or mitigating against risks associated with the use and manufacture of devices.
  • Ensuring their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work
  • Establish, implement and maintain an effective quality management system, as the needs for the business changes
  • Reporting to top management on the performance of the quality management system, and ensuring the promotion of awareness of regulatory requirements throughout the organization.
  • Ensuring compliance to regulatory requirements appropriate to the quality management system; medical device ISO standards, including ISO13485:2016 & ISO14971:2007 and Medical Device Regulations, including MDD93/42/EEC, MDR/2017/745, SOR/98-282, 21CFR820, TGMDR & RDC 16/2013.

Key Responsibilities
  • Maintain the quality management system in compliance with all existing regulatory approvals.
  • Lead the required changes to the Quality Management system to ensure a timely compliance to MDR/2017/745
  • Develop and manage the post-approval regulatory processes, including country registration / vigilance / post market surveillance etc.
  • Management Representative for the company
    • Reporting the performance of the quality system and any need for improvement to executive management; and
    • Promote awareness of regulatory and customer requirements throughout and Serving as the company's liaison with customers and other outside concerns on matters related to product quality and reliability.
    • Lead all audits from external regulatory bodies and customers.
    • Regulatory Correspondent under the requirements of SOR 98/282 as follows;
  • license renewal and voluntary withdrawal;
  • responses to requests for additional information from Health Canada, including submission of QMS documents and records related to post-market actions (mandatory problem reporting, complaints, recalls); maintenance of documentation and records related to the Manufacturer’s QMS (including design history file, manufacturing specifications); or
  • iii. maintaining records and/or copies of licenses (including information submitted to support a license application or amendment).
  • Identify, interpret & manage product and system changes to identify which could potentially affect compliance to existing regulatory approvals.
  • Monitor the suitability and effectiveness of the Quality System and assure compliance with current US and international regulations and ISO standards.
  • Direct continuous improvement of the system to meet the evolving expectations of customers, business partners and regulators
  • Advise Key Staff of compliance/non-compliance with current international regulations, policies and EC directives
  • Provide recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer.
  • Interface with other functions in a team environment providing Quality and Regulatory input & leadership.
  • Provide technical support when required for the manufacture of existing products and the growth and development / transfer of new products / technologies.
  • Ensures internal audits and other activities covered under the Quality Manual, Policies & Procedures are executed.
  • Develop Quality Plans for principle products and product lines.
  • Maintain control of nonconforming material and product.
  • Develop Inspection Plans and supporting documents that specify inspection and test requirements and sampling levels.
  • Manage supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions

Skills, Qualifications & Experience
  • A graduate of Engineering/Sciences with Minimum 6 years’ experience in a pharmaceutical/Medical Device environment
  • Extensive knowledge of quality management systems and current international and European regulations/standards with respect to medical devices.
  • Excellent interpersonal and communication skills with good leadership abilities; high level of self-motivation
  • Demonstrable ability to work in a multi-disciplinary, regulated environment
  • The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

For further information on this Quality Assurance Manager role in Galway please contact Bimi Felix on 086 8395533 /

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