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Regulatory Affairs Manager

Critical Healthcare is a leader in the Emergency Services market providing healthcare solutions that enable our customers to do what they do best, deliver patient care at the front line. Through our cloud-based software, Medlogistix, we offer a managed service which ensures a transparent procurement process fully supported by scheduled product delivery across all categories.

As a specialist within Emergency Services, our customers have full access to our transformational software and best in class products across medical consumable, PPE or medical device portfolios.
Our ability to offer an innovative, pre-approved end to end authorised solution secures not only tangible cost savings but a compliant and time efficient method within this high-pressured environment where remote digital access reduces the already scarce resources in this sector.

Our customers across Europe have entrusted us to be their single supplier for all their medical consumables. Today we have operations/sales in Ireland, UK, Germany, Denmark, Spain, Sweden, Austria, Poland and France. We are the sole supplier to the National Ambulance markets in Ireland & Denmark and the exclusive supplier to Falck across Europe, keeping ambulance on the road ‘day & night’ with all their essential medical requirements.

Description of role:

  • Create and maintain audit friendly product file for customers and HPRA assurance. A reliable & compliant supply chain is
  • essential to the future of our expansion and indeed our current business trading, particularly with issues Brexit is resenting.
  • A key element to our expansion will be the certification of ISO 13485. This is strongly linked to our core value, customer service
  • and therefore is strongly linked to our future goals for expansion in Europe and the US.
  • Identify products compliant or not with regulatory requirements in our current markets and liaise with non-compliant suppliers
  • Research alternative EU based suppliers, improving our supply chain capability
  • Evaluate, and authorize if appropriate, changes to the manufacturing and supply chain processes
  • Approve product labels, package inserts and Marketing material

Desired Skills & Experience:

  • As appropriate, manage CE mark Submissions / Significant Changes and Notified Body interactions.
  • Manage Regulatory Assessment of any Device / Quality System changes, and any subsequent notifications that are required to
  • be made to Regulatory Agencies.
  • Work with the Commercial Team to ensure country specific registration activities are understood and appropriately addressed.
  • Lead Management Review process; report on the performance of the Quality System
  • Manage Design Control, Change Control, CAPA, Risk Management, Product Vigilance and Document Control Systems
  • Lead strategic quality improvement projects and initiatives which enhance the long-term sustainability of Critical Healthcare,
  • including technology transfer and process improvement projects
  • Evaluate, and authorize if appropriate, changes to the manufacturing and supply chain processes
  • Approve product labels, package inserts and Marketing material
  • Lead product and facility inspections, preparation of procedures and instructions including certification assessment and
  • surveillance audits, HPRA, WHO inspections, other regulatory inspections and supplier audits
  • ISO 13485 Management representative, manage all correspondence with Notified Body in order to achieve certification
  • In order to coordinate the variety of regulatory related tasks, the role requires a high degree of flexibility, and structured time
  • and task management.

Education/Experience:

  • A minimum of a degree in a Quality/Engineering/Science or related discipline, and at least 1 years’ experience in a medical
  • device/healthcare industry in a regulatory position.
  • Applicants with experience in quality with additional experience in regulatory will also be considered.
  • Excellent verbal and written communication skills.
  • Excellent attention to detail skills.

Specific Requirements:

  • The person must be a "self-starter" in terms of time and task management, and be able to operate with minimal supervision.
  • Possess strong Technical Writing ability.
  • Have a methodical review approach, and be capable of initiating and leading change and continuous improvement.
  • Ability to work within a team environment to achieve agreed company goals.
  • Good understanding of ISO 13485 and FDA QSR quality standards.
  • Analytical mindset and critical thinking
  • Excellent communication and interpersonal skills
  • Ability to quickly digest large amounts of data, perform analysis and identify trends to make business decisions based on data.
  • Excel expertise is a bonus.
  • Excellent attention to detail.

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