REGULATORY AFFAIRS SPECIALIST

REGULATORY AFFAIRS SPECIALIST (Contract) Maple Grove, MN, United States (On-site) Contract (1 year 5 days) Published 3 days ago Compliance & Regulatory Affairs CAPA implementation FDA regulations cross - functional collaboration Documentation & Audits 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. Key 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. Required Qualifications: 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. The pay range that the employer in good faith reasonably expects to pay for this position is $39.30/hour - $61.40/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis. Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations. #J-18808-Ljbffr Capgemini