Senior Compliance Engineer

Recruiter
HERO Recruitment
Employment Type
Permanent
Salary
Not disclosed
HERO Recruitment logo

Senior Compliance Engineer

We know it’s not all about the money when you’re looking for your next Senior Compliance Engineer job but we also know it’s important too! HERO are working with a global leader in Medical Devices to find the very best of talent for their Limerick operation. Why should you apply? This Senior Compliance Engineer job opportunity in Limerick offers exceptional career development opportunities whilst delivering excellent salary and benefits package. Let’s talk to see if this is the right move for you.

Purpose
You will be involved in R&D projects for New Product Introduction and Product maintenance (mechanical, electrical, software design….) and will interact with key functions across the Worldwide organization (R&D, Operations, Reg Affairs, Marketing, Medical Affairs) and external projects partners (key suppliers, contract labs, CMOs)

Main Responsibilities

  • Manage the relationship with 3rd party testing and certification providers
  • Own the compliance plan
  • Answers question from the providers during certification exercises.
  • Obtain product certification for approvals to sell products in the global marketplace.
  • Ensuring test procedures or protocols are aligned or are updated accordingly
  • Creates guidance to drive harmonization across the organization
  • Serves as SME and trains associates
  • Updates job knowledge by tracking and understanding emerging compliance engineering practices and standards; participating in educational opportunities and professional organizations; reading professional publications; maintaining personal networks
  • Support investigation for Issues related to product design
  • Provide support to internal and regulatory body audits and associated corrective actions.

Key requirements

  • Engineer with a experience in Quality Management
  • 6+ years industry experience (Healthcare/Pharmaceutical/Biologics/Medical Devices)
  • Project experience
  • Experience working with cross-functional teams and remote teams, promote work in multidisciplinary teams
  • General understanding of Design Control, FMEA/Risk Management
  • Understanding of industry regulations/standards: ISO 13485, QSR, 21CFR820, ISO
  • Rigor and good organization
  • Ability to act as Change Agent and effectively manage change
  • Strong interpersonal skills : Demonstrate strong and clear accountability for successful and timely completion of tasks
  • Influence: Intuitively and quickly assess people and situations and act accordingly. Demonstrate persuasion and timing skills.
  • Prefer infusion pump experience or drug delivery experience (regulated FDA industry

For further information on this role in Limerick please contact Aisling Kidney on or

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Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.