Science & Pharmaceutical JobsRegulatory Affairs Specialist

  • 51634
  • Permanent
  • Offaly, Westmeath

Collins McNicholas

Job Title:  Regulatory Affairs – Specialist role. 
Location:   Tullamore, Offaly
Company: Healthcare Solutions
Permanent position – Hiring Now!

Overview of the long-term tasks:

  1. 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 the issues Brexit is presenting.
  2. A key element to the 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.
  3. Identify products compliant or not with regulatory requirements in our current markets and liaise with non-compliant suppliers
  4. Research alternative EU based suppliers, improving our supply chain capability
  5. Evaluate, and authorize if appropriate, changes to the manufacturing and supply chain processes
  6. 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 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.

For more information and a confidential discussion please contact Mary Mullin.

mary.mullin@collinsmcnicholas.ie

090 6478104 / 085 8718281

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