Regulatory Affairs Specialist

Sigmar Recruitment; Galway; On-site; EUR 45,000 - 65,000; Full time

Job summary

Sigmar Recruitment in Galway seeks a Regulatory Affairs Specialist for a medical device company. The role concentrates on US FDA submissions and EU regulatory requirements, with risk management and design assurance embedded in product lifecycles.

You will collaborate with cross-functional teams to ensure registrations across global markets, maintain DHF, and support ongoing compliance. A minimum of one year in regulatory affairs in medical devices is desired.

Qualifications

• Minimum of one year in Regulatory Affairs or design assurance in medical devices.
• Degree in Mechanical, Materials, Polymer or Biomedical Engineering or related field.
• Knowledge of EN ISO 14971 risk management.
• Experience with US FDA submissions (510(k), PMA) is a plus.

Responsibilities

• Develop global regulatory strategies for medical devices in collaboration with regulatory management.
• Prepare and coordinate US FDA submissions including 510(k), HDE, IDE and PMA.
• Maintain understanding of global medical device regulations and harmonised standards.
• Liaise with regulatory authorities to support timely product approvals and registrations.
• Support products through regulatory changes, licenses and ongoing compliance.
• Lead design reviews in line with EU and FDA requirements.
• Maintain DHF and manage design quality records.
• Lead risk management and prepare risk docs including FMEAs per ISO 14971.
• Collaborate with design teams on testing requirements and V&V plans.
• Support testing related to sterilisation, biocompatibility and stability.
• Ensure product quality aligns with regulatory requirements.
• Prepare checklists for harmonised standards and support the regulatory function.

Skills

Regulatory knowledge

Attention to detail

Cross-functional collaboration

Communication skills

Education

Bachelor's or Master's in Mechanical/Materials/Biomedical Engineering or related field

Tools

DHF management

Job description

Regulatory Affairs Specialist

Location: Galway, Ireland
Sector: Medical Devices

About the Role

We are seeking a Regulatory Affairs Specialist to join a medical device organisation in Galway. This is an excellent opportunity for a regulatory professional with experience in medical devices, design assurance or a related technical field to contribute to product approvals, regulatory compliance and the ongoing commercialisation of medical devices across global markets.

The role will have a particular focus on US FDA regulatory submissions, alongside EU regulatory requirements, risk management and design assurance activities. You will work closely with cross-functional design and regulatory teams to ensure products meet the necessary regulatory and quality standards throughout their lifecycle.

Key Responsibilities

• Develop and support global regulatory strategies for medical devices in collaboration with regulatory management.

• Prepare and coordinate US FDA regulatory submissions, including 510(k), HDE, IDE and PMA applications.

• Maintain a strong understanding of global medical device regulations, FDA guidance, EU requirements and applicable harmonised standards.

• Liaise with regulatory authorities to support timely product approvals and maintain existing product registrations.

• Support marketed products through regulatory change notifications, licence renewals and ongoing compliance activities.

• Lead design reviews in accordance with internal procedures and applicable EU and FDA requirements.

• Maintain Design History Files (DHF) and ensure accurate management of design quality records.

• Lead risk management activities and prepare risk management documentation, including Design and Use FMEAs, in line with ISO 14971.

• Collaborate with design teams to define product testing requirements and prepare design verification and validation plans, protocols and reports.

• Support testing activities relating to sterilisation, biocompatibility, stability and transportation.

• Ensure product quality standards and specifications align with relevant regulatory and company requirements.

• Prepare standard checklists covering applicable harmonised standards and support the wider regulatory affairs function as required.

Skills, Qualifications & Experience

• A minimum of one year of experience in Regulatory Affairs, Design Assurance or a similar role within the medical device industry.

• A primary or postgraduate degree in Mechanical, Materials, Polymer or Biomedical Engineering, or another relevant technical discipline.

• Knowledge and practical experience of risk management methodologies in accordance with EN ISO 14971.

• Working knowledge of US FDA requirements, including 21 CFR 820, EU Medical Device Directive 93/42/EEC and applicable harmonised standards.

• The ability to interpret and apply regulatory requirements in a practical medical device environment.

• Previous experience preparing or supporting US FDA submissions is a distinct advantage.

• Strong attention to detail and the ability to manage regulatory documentation and collaborate effectively with cross-functional teams.

Why Apply?

• Opportunity to develop your regulatory affairs career within the medical device sector.

• Exposure to US FDA submissions and international regulatory requirements.

• Involvement in design assurance, risk management and product verification and validation.

• The chance to work collaboratively with technical and regulatory teams across the medical device product lifecycle.