Regulatory affairs specialist

Responsibilities

• Lead regulatory activities supporting product corrections, recalls, and field actions.
• Partner with internal global regulatory teams and external regulatory authorities regarding recall-related communications and submissions.
• Manage Product Incident Reports (PIRs), including investigation, risk assessment, documentation, and regulatory reporting.
• Drive development, implementation, and monitoring of CAPAs to address nonconformances and improve regulatory processes.
• Support internal and external audits, inspections, and compliance assessments.
• Ensure compliance with FDA regulations, EU MDR requirements, and other international regulatory frameworks.
• Monitor evolving global regulatory requirements and communicate regulatory updates to stakeholders.
• Provide regulatory guidance for post-market surveillance and quality-related activities.
• Develop and deliver regulatory compliance training to internal teams.
• Collaborate with Quality, Clinical, Engineering, Manufacturing, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related scientific/technical discipline, along with 12+ years of relevant industry experience.
• Minimum 5 years of experience in Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences industry.
• Minimum 2 years of direct Regulatory Affairs experience.
• Strong knowledge of U.S. FDA regulations and medical device regulatory requirements.
• Experience managing: Product Incident Reports (PIRs); Corrective and Preventive Actions (CAPAs); Product recalls and field corrective actions; Audit and inspection support activities.
• Experience using regulatory systems, databases, and documentation tools.
• Strong written and verbal communication skills.