Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or related field.
12+ years of relevant industry experience.
Minimum 5 years in Regulatory Affairs and/or Quality in medical device or healthcare sector.
At least 2 years of direct experience in Regulatory Affairs.
Strong knowledge of U.S. FDA regulations and medical device compliance.
Responsibilities
Lead regulatory compliance for product corrections, recalls, and field actions.
Collaborate with internal teams and regulatory authorities on recall communications.
Manage and assess Product Incident Reports (PIRs) with detailed documentation.
Develop and implement Corrective and Preventive Actions (CAPAs).
Support audits and compliance assessments internally and externally.
Ensure adherence to FDA regulations and international standards.
Monitor and communicate updates on global regulatory requirements.
Benefits
Opportunity to work in a dynamic and critical field with global impact.
Collaborative work environment with cross-functional teams.
Access to continuous professional development and training in regulatory affairs.
Influence and drive compliance improvements within product lifecycle.
Full Job Description
Job Description:
Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This role is responsible for ensuring compliance with global regulatory requirements related to product incident reporting, corrective and preventive actions (CAPA), recalls, field actions, audits, and post-market surveillance activities.
The ideal candidate will possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and the ability to collaborate effectively across cross-functional teams to drive compliance and continuous improvement initiatives.
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.
udit and inspection support activities.
Experience using regulatory systems, databases, and documentation tools.
