Quality and Regulatory Affairs Manager - Viecura

Location: Dungarvan, Co. Waterford, Ireland
Job Type: Full-Time, Permanent

Are you ready to make a real difference in healthcare?
At Viecura, we design innovative medical products that improve lives.
With a focus on patient-centered solutions, diversity, and inclusion, we empower our team to drive meaningful change in the industry.

We’re expanding our team in Ireland and are seeking a Quality and Regulatory Affairs Manager to join us in Dungarvan, County Waterford. Whether you’re an experienced professional or a recent graduate with relevant qualifications, this is an opportunity to lead quality operations in a fast-growing global company.

What You’ll Do:

As a Quality and Regulatory Affairs Manager, you will:

Lead Quality Systems: Develop and maintain best-in-class systems for Class 1 and Class 2 medical and surgical textiles.
Ensure Compliance: Oversee adherence to US FDA 21 CFR Part 820, MDR, ISO 13485, ISO 14001, and related regulations.
Collaborate Globally: Work with colleagues in the USA and China to align quality and regulatory strategies.
Drive Growth: Scale quality operations to support EU expansion and enhance compliance systems.
Be the Voice of Quality: Act as the site Management Representative and 'Person Responsible for Regulatory Compliance' (PRRC).
Build a Strong Team: Lead and inspire a high-performing quality team to achieve industry-leading standards.
Liaise Externally: Represent the company in quality-related matters with external parties.

What We’re Looking For

To succeed in this role, you’ll bring:

Qualifications: A minimum bachelors degree in regulatory affairs, engineering, chemistry, or life sciences.
Expertise: Knowledge of MDR, FDA, GMP, ISO 13485, and ISO 14001, and qualification as an ISO 13485 lead auditor.
Problem-Solving Skills: Analytical thinking and strong project planning skills.
Collaboration: A self-motivated, team-oriented attitude with excellent communication skills.

Why Join Viecura?

We offer:

Competitive Salary: Reflecting your skills and experience.
Time Off: 25 days of annual leave.
Career Growth: Exciting opportunities for personal and professional development.
Global Experience: Work with leading healthcare companies worldwide.
Team Events: Regular company events to celebrate our shared success.
CSR Day: A dedicated day to give back to the community.
Sustainability Support: Bike-to-work scheme.
Unique Work: Make a genuine difference in the world.

Ready to Make a Difference?

If you’re excited about joining a company dedicated to shaping the future of healthcare, we want to hear from you!

Apply now to join our mission to improve patient-centered care through innovative solutions.

Viecura Group is an Equal Opportunity Employer.

Job Types: Full-time, Permanent

Additional pay:

Bonus pay

Benefits:

Bike to work scheme
Company events
On-site parking

Schedule:

Monday to Friday

Work Location: In person

Viecura Group

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Quality and Regulatory Affairs Manager