Sign upLog in
Regulatory Affairs Jobs in Minnesota

Regulatory affairs specialist

Talent Software Services, Inc.

Maple Grove, MN

Apply
JOB DETAILS
SALARY
$50–$55 Per Hour
SKILLS
Analysis Skills, Biology, Cardiology, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, External Audit, FDA Requirements, Healthcare, Healthcare Quality, Internal Audit, Maintain Compliance, Manufacturing, Maple, Medical Equipment, Monitor Regulations, Presentation/Verbal Skills, Process Improvement, Product Lifecycle, Product Management, Product Support, Regulations, Regulatory Compliance, Regulatory Reports, Regulatory Requirements, Risk Analysis, Surveillance, Team Player, Training/Teaching, Writing Skills
LOCATION
Maple Grove, MN
POSTED
1 day ago
Possible 3 Month CTH
Role: Regulatory affairs specialist
Work location: Hybrid, Maple Grove, Minnesota (3 days onsite weekly)
Background and Meet and Greet: MANDATORY

Job Description:
Position Summary
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:
o Product Incident Reports (PIRs)
o Corrective and Preventive Actions (CAPAs)
o Product recalls and field corrective actions
o Audit and inspection support activities
" Experience using regulatory systems, databases, and documentation tools.
" Strong written and verbal communication skills. "

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.


What are the Mandatory skills and skill proficiencies required for this position?
" 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:
o Product Incident Reports (PIRs)
o Corrective and Preventive Actions (CAPAs)
o Product recalls and field corrective actions
o Audit and inspection support activities
" Experience using regulatory systems, databases, and documentation tools.
" Strong written and verbal communication skills



About the Company

T

Talent Software Services, Inc.

Resume Resources

Free Resume TemplatesFree Resume Builder

Similar Job Searches

Remote Government JobsEntry Level Government Jobs