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Regulatory Affairs Project Leader
2 weeks ago
Looking for candidates local to the Maple Grove MN or St Paul MN area. This is an onsite position.
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:
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
• 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
