Regulatory affairs specialist

Katalyst CRO; Minneapolis (MN); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO is seeking a highly experienced Principal Regulatory Affairs Specialist to lead global post-market regulatory compliance across Interventional Cardiology and Vascular Therapies. The role ensures adherence to FDA and international regulatory requirements, CAPA and PIR governance, recalls, and field actions while collaborating with cross-functional teams.

The ideal candidate will have deep knowledge of U.S.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or related field; 12+ years of industry experience.
• Minimum 5 years of experience in Regulatory Affairs and/or Quality within medical devices/healthcare.
• Minimum 2 years of direct Regulatory Affairs experience.
• Strong knowledge of U.S. FDA regulations and medical device regulatory requirements.

Responsibilities

• Lead regulatory activities supporting product corrections, recalls, and field actions.
• Partner with internal global regulatory teams and external authorities regarding recall communications and submissions.
• Manage Product Incident Reports (PIRs), including investigation, risk assessment, documentation, and regulatory reporting.
• Drive development and monitoring of CAPAs to address nonconformances and improve regulatory processes.
• Support audits, inspections, and compliance assessments.
• Ensure compliance with FDA regulations, EU MDR, and other international regulatory frameworks.
• Monitor evolving global regulatory requirements and communicate 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 lifecycle compliance.

Skills

Regulatory affairs

FDA regulations

CAPA management

PIRs management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences/Engineering/Regulatory Affairs

Tools

Regulatory systems

Documentation tools

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.

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.
• Audit and inspection support activities.
• Experience using regulatory systems, databases, and documentation tools.
• Strong written and verbal communication skills.