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Job Requirements of Regulatory Affairs Project Leader:
-
Employment Type:
Full-Time
-
Location:
Saint Paul, MN (Onsite)
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Regulatory Affairs Project Leader
Collins Consulting, Inc
Saint Paul, MN (Onsite)
Full-Time
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
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
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