Regulatory Affairs Manager (Medical Devices)

TL;DR

Regulatory Affairs Manager (Medical Devices): Develop and execute global regulatory strategies for medical device commercialization and compliance with an accent on US, EU, and international regulations including FDA and EU MDR. Focus on leading regulatory submissions, assessing impacts of product changes, and providing expert guidance across product lifecycle.

Location: Ballina, Ireland (onsite)

Company

Independent, employee-owned company developing, manufacturing, and marketing healthcare products for ostomy care, continence care, and critical care worldwide.

What you will do

• Develop and implement global regulatory strategies for new products, lifecycle management, and market access.
• Lead preparation, review, and support of regulatory submissions, registrations, renewals, and change notifications.
• Assess regulatory impacts of changes in products, labeling, manufacturing, and secure approvals.
• Provide expertise on regulations like 21 CFR Part 820 (US), EU MDR, Canada MDR, Brazil RDC, Japan PMD Act, Australia TG(MD)R.
• Support PRRC or EU AR responsibilities, maintain technical documentation and compliance records.
• Collaborate with R&D, Quality, Clinical, Operations, Marketing, and external partners on compliance projects.
• Review labels, IFU, promotional materials; support post-market surveillance, audits, and act as liaison with authorities.
• Deliver regulatory training and monitor industry best practices.

Requirements

• Bachelor’s Degree with 8-12 years of related experience in regulatory affairs for medical devices
• Deep knowledge of global regulations: US FDA, EU MDR/IVDR, Canada, Brazil, Japan, Australia
• Experience with regulatory submissions, PRRC/EU AR roles, audits (MDSAP, ISO 13485, ISO 14971)
• Strong cross-functional collaboration and communication skills
• Ability to manage multiple priorities, travel frequently (including overnight), and lift up to 15 pounds occasionally

Nice to have

• Master’s degree
• Regulatory credential (e.g., RAC from RAPS)

Culture & Benefits

• Employee-owned company focused on mission to make life more rewarding and dignified
• Agile, customer-centric, people-focused, performance-driven culture
• Opportunities for innovation, process improvements, and participation in industry working groups
• Global operations with manufacturing and distribution on three continents