Hours: 8:00am-5:00 PM

: local to the Maple Grove MN or St Paul MN area- Could potentially be a Hybrid role; however, if converted, it will be 4-5 days per week onsite.

Duration: This is a 6-month contract with potential to extend or convert highly likely

• The Global Regulatory Services (GRS) Quality Compliance Project Lead is responsible for supporting the RA procedure harmonization and related maintenance activities post harmonization.
• Regulatory processes have been harmonized across 6 Client medical device business units
• Support GRS owned CAPA activities related to RA procedural changes.
• These activities include managing GRS CAPA tracker, quality review for verification, lead CAPA correction and corrective action delegated activities and tasks.

TOP 5 Desired qualifications and experience:

• Procedural Writing
• CAPA Expertise
• Project management skills – organize and lead meetings for procedural development
• 5+ years’ experience in a regulated industry
• Familiarity with Regulatory Affairs departmental responsibilities and processes

Desired Qualifications

• Bachelor’s Degree
• Quality Systems experience desired
• Must understand regulatory processes and be quality system oriented and have a background in both areas
• Technical writing skills
• Strong communication skills (written and verbal)
• Proven success managing multiple projects and priorities
• High Attention to detail
• Proficient in Microsoft Word, Visio, and PowerPoint
• Windchill experience a Plus but not Required

Global Regulatory Services Quality Compliance Project Lead – GRS-QC Project Lead

Job Description:

• The Global Regulatory Services Quality Compliance Project Lead is responsible for supporting the RA procedure harmonization and related maintenance activities post harmonization.
• Regulatory processes have been harmonized across 6 Client medical device business units: Vascular, Neuromodulation, Structural Heart, Electrophysiology, Cardiac Rhythm Management, Heart Failure.
• This position will require strong project management skills to drive meetings and business unit process alignment.
• This person will report to the Global Regulatory Operations – Quality & Compliance Manager.
• They will work with the cross-business unit RA harmonization teams to update procedures, obtain cross functional review, route documents through the change order process and revise training audiences as necessary.
• This person will get experience structuring procedures, work instructions and guidance documents within the Client Quality Systems.

Responsible for:

• Lead procedural updates and emerging regulation implementation working with cross BU/ cross functional teams
• Drive change order activities, supplemental training materials and related implementation activities
• Review and follow document quality system structure
• Develop, redline, and compile feedback on GRS owned procedure, work instructions, forms, and templates
• Lead team meetings and document meeting minutes
• Develop and implement process related training material
• Facilitate procedure implementation

RA QA experience desired:

• Regulatory Change Assessment
• International Product Registration support
• Procedural Writing
• Ad and Promotional Material - Regulatory Review
• Project management skills – organize and host meetings
• Quality System maintenance activities
• Documenting Justification for change from Regulatory perspective

Qualifications/Skills desired

• Bachelor’s Degree
• 5+ years experience in a regulated industry
• Familiarity with Regulatory Affairs departmental responsibilities and processes
• Independent Problem Solving
• Technical writing skills
• Strong communication skills (written and verbal)
• Proven success managing multiple projects and priorities
• Attention to detail
• Proficient in Microsoft Word, Visio, and PowerPoint
• CAPA experience
• Windchill experience

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