Regulatory affairs specialist

Creative Solutions Services, LLC; Minneapolis (MN); On-site; USD 130,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Principal Regulatory Affairs Specialist to lead global post-market regulatory compliance for Interventional Cardiology and Vascular Therapies. You will oversee PIRs, CAPA programs, recalls, field actions, and audits while guiding cross-functional teams on regulatory requirements.

You will apply deep knowledge of U.S. FDA regulations and international frameworks to ensure continuous compliance and drive process improvements across the organization.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or related discipline; 12+ years of experience.
• Minimum 5 years in Regulatory Affairs and/or Quality in medical devices, healthcare, or life sciences.
• 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 regulatory authorities for recall-related communications and submissions.
• Manage Product Incident Reports (PIRs) including investigation, risk assessment, documentation, and regulatory reporting.
• Drive CAPA development, implementation, and monitoring to address nonconformances and improve processes.
• Support internal and external audits, inspections, and compliance assessments.
• Ensure compliance with FDA regulations, EU MDR requirements, and other international frameworks.
• Monitor evolving 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 throughout product lifecycle.

Skills

Regulatory affairs

FDA regulations

CAPA management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences/Engineering

Tools

Regulatory databases

RIM systems

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