Regulatory Affairs Project Leader

This is a hybrid role and looking for candidates local to Maple Grove, MN or St Paul, MN area.

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

Job Description:
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. 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 Senior Manager. 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. They will work with the cross-business unit RA compliance 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
• Review and approval of CAPAs with attention to detail, review of completeness, accuracy, effectivity and timeliness
• Drive change order activities, supplemental training materials and related implementation activities
• Execute CAPA Review board/Management Review forums
• 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
• Identify continuous improvement and collaboration opportunities

Top 5 Desired qualifications and experience:
1. Procedural Writing
2. CAPA Expertise
3. Project management skills organize and lead meetings for procedural development
4. 5+ years experience in a regulated industry
5. Familiarity with Regulatory Affairs departmental responsibilities and processes

Desired Qualifications

• Bachelor s Degree
• Quality Systems experience desired
• 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
• Windchill experience (not Required, but a Plus)