FDA Submissions Lead – Medical Devices

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

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.