The Freudenberg Group, a global technology group with 48,000 employees in some 60 countries, develops leading-edge technologies, and excellent products, solutions and services for more than 30 market segments. Freudenberg & Co. Kommanditgesellschaft, with its Headquarter in Weinheim, is the strategic parent company of the broadly diversified Group. Freudenberg Medical is a leading global manufacturer of components for medical devices, complex catheter systems for minimally-invasive surgery and total solutions for the biotech, healthcare and pharmaceutical industries.

Medical Device - Regulatory Compliance Engineer
2-3 years Medical Device regulatory experience

Your tasks

  • Assist the QA/RA and Env Manager, RA Manager and Quality Compliance manager in the co-ordination, maintenance & integration of the Quality & Environmental Management Systems within the organisation in accordance with the requirements of ISO 13485, ISO 14001 and FDA QSR.
  • Responsible for the control and implementation of the VistaMed Customer and Regulatory Audit schedules, including:
    • preparation activities related to both internal and external (customer and regulatory) audits (pre-planning meetings and action tracking)
    • communication with customers regarding the scheduling of customer audits.
    • take the lead in customer and /or regulatory audits as required.
    • responding to any findings related to customer or regulatory audits
  • Responsible for the Corrective and Preventive Activities pertaining to any findings or observations from customer or regulatory audits.
  • Participation in the site:
    • CAPA process
    • Internal Audit process
    • ECR (Engineering Change Request) process
    • Training process
    • Document Control process
    • Management Review process
    • Monthly Operations reporting process
    • Vendor Management process
  • Assist the Regulatory Affairs Manager and/or Quality Compliance Manager with the maintenance of the Quality and Environmental Management Systems.
  • Participate in the Freudenberg Medical – Unified Quality System (UQS).
  • Assist with the site(s) regulatory requirements related to REACH, RoHS, CLP, etc.
  • Deputise for the RA and/or QC managers as required.

Our expectations

  • Degree qualified or higher in Quality and/or Technical with focus on Medical or Pharma sectors.
  • Minimum of 5 years working in a regulated environment (medical/pharma)
  • Must have experience dealing with customer and regulatory audits relating to ISO 13485 and/or FDA QSR 21 CFR part 820.
  • Must have in-depth knowledge of the ISO and FDA regulations.
  • Knowledge of Medical Device Directive 93/42 EEC, new Medical Device Regulation, and related MEDDEVs, preferred.  
  • Experience preparing 510K pre-market submissions and CE Marking applications, preferred.
  • Certified internal auditor (Lead Auditor certified preferred)       
  • Knowledge of ISO 14001 Environmental Regulations an advantage.  

Freudenberg Medical is a global partner for the design, development, and manufacture of innovative medical device technologies.  We offer the following services to medical device, pharmaceutical and IVD clients worldwide - product design and development, silicone and thermoplastic moulding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer that medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Freudenberg Medical maintains design and manufacturing centres in California, Indiana, Massachusetts, Minnesota, Costa Rica, Europe and Asia. 

VistaMed, a Freudenberg Medical Joint Venture Company are a leading provider of complex extrusions, finished catheters and devices to the minimally invasive medical device industry. We are a “one stop shop” solution for the Design, Manufacture, Assembly, Sterilisation and Distribution of Catheters. VistaMed’s Culture is positive and very team orientated. In our workplace environment, we are enthusiastic about helping others with our innovative medical devices. Our Company is very driven to be a leader in the Medical Device sector, and always eager to improve the quality of life in the patients in which we serve.

VistaMed is a local, innovative, high growth company with a collaborative, high performance work environment. Our highly talented teams of committed employees enable us to be the best, remain leaders in our field, and deliver first-class service to our clients. We understand that our team drive the company and therefore we are committed to ensuring personal development, safety, happiness and prosperity for all our employees.

Location: Carrick-on-Shannon, Co. Leitrim, Ireland

We are currently hiring a Regulatory Compliance Engineer:

  • Self-motivated, thrives in a fast-paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
  • Strong interpersonal and communications skills.
  • Ability to manage multiple tasks and adapt in a challenging, fast paced environment.

It’s an exciting time to work in VistaMed. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus benefits. Learn more at www.vistamed.net or www.freudenbergmedical.com

Freudenberg Medical and VistaMed are an equal opportunity/affirmative action employer

Do you have any questions?

Freudenberg Medical - VistaMed
Eithne Ní Bhrádaigh ∙ Human Resources ∙ IDA Business and Technology Park ∙ N41 N8C9 Carrick-on-Shannon, Co. Leitrim, Ireland
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