To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Pay Range - $60 to $75/hr. (negotiable)

Job Description:
Job Roles & Responsibilities:

• Hours: 8:00am-5:00 PM
• Location: Please submit candidates local to the Maple Grove MN or St Paul MN area
• Could potentially be a Hybrid role; however, if converted, it will be 100 percent 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 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.
• 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 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 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:

• 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 of these areas
• Technical writing skills
• Strong communication skills (written and verbal)
• Proven success managing multiple projects and priorities
• High Attention to detail
• Proficient in MS Word, Visio, and PowerPoint
• Windchill experience a Plus but not Required