Working at Freudenberg: "We will wow your world" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.
Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.
Some of your Benefits
Health Insurance
Company Pension
Flexible Work Models
Personal Development
Diversity & Inclusion
Carrick-on-Shannon, Co. Leitrim
On-Site
VistaMed Ltd.
You will support our team as a
REGULATORY COMPLIANCE ENGINEER
Responsibilities
* Join a leading global medical device company where you'll have a direct impact on ensuring our products meet the highest regulatory and quality standards worldwide.
* Work at the heart of compliance - supporting, maintaining, and improving our Quality & Environmental Management Systems across ISO 13485, ISO 14001, and FDA QSR requirements.
* Play a key role in external and internal audits: planning, coordinating, leading customer and regulatory audits, and guiding the organisation through findings and corrective actions.
* Take ownership of Post Market Surveillance and Vigilance activities, helping ensure patient safety and ongoing product performance.
* Be the compliance expert that teams rely on - supporting CAPA, Change Control, Document Control, Training, Vendor Management, and other core quality system processes.
* Work closely with Quality and Regulatory leaders, contributing to global initiatives and the Freudenberg Unified Quality System.
* Collaborate across departments to keep our compliance frameworks strong, effective, and inspection-ready at all times.
* Support environmental and chemical regulatory requirements (REACH, RoHS, CLP), ensuring the business stays ahead of evolving standards.
* For senior candidates: lead and mentor team members involved in change management and inspection activities, helping drive continuous improvement across the site.
Qualifications
* A Degree in Quality, Engineering, Science, or a technical discipline related to Medical Devices or Pharmaceuticals.
* At least 5 years of experience in a regulated MedTech or Pharma environment (6+ years for Senior level).
* Strong experience preparing for and participating in ISO 13485 and/or FDA QSR 21 CFR 820 audits - with confidence interacting with regulators and customers.
* Deep knowledge of ISO and FDA regulations, with additional exposure to ISO 14001, MDR 2017/745, or MDD 93/42/EEC seen as a strong advantage.
* Certified Internal Auditor (Lead Auditor certification preferred).
* Experience supporting CAPA, internal audits, PMS, vigilance, or other core quality system elements.
* Previous supervisory experience is beneficial - and required for those interested in the Senior Engineer position.
* A proactive mindset, strong attention to detail, and genuine enthusiasm for improving systems, solving problems, and working cross-functionally in a fast-paced environment.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Additional Information
Emma Reynolds