Regulatory affairs specialist W2 role

Role: Regulatory affairs specialist 
Location: Hybrid Maple Grove Minnesota (3 days onsite weekly)
Job Type: Contract (C2C/W2)
Interview: Phone/Video

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.

What are the Mandatory skills and skill proficiencies required for this position
   Bachelors 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
 

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Contract