York Solutions, LLC
Regulatory Affairs Project Leader
York Solutions, LLC, Osseo, Minnesota, United States, 55311
Description
At this time, we are unable to consider candidates requiring visa sponsorship or third-party recruitment agencies for this role. We encourage all applicants to apply directly, and we thank you for your understanding.
Apply now, read the job details by scrolling down Double check you have the necessary skills before sending an application. Overview: 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 Abbott 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.
Location: Onsite - Maple Grove, MN or St Paul, MN (must be local to MN)
Responsibilities:
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
Required Qualifications:
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
Preferred 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)
Benefits: York Solutions Offers a generous benefits package for eligible full-time employees: BCBS Medical with 3 Plans to choose from (PPO and High deductible PPO plans with Health Savings Program) Delta Dental plan with 2 free cleanings and insurance discounts Eye Med Vision with annual check-ups and discounts on lens Life and Accidental Death Insurance paid by company John Hancock 401(k) Retirement Plan with discretionary company match up to 5% Voluntary Insurance programs such as: Hospital Indemnity, Identity Protection, Legal Insurance, Long Term Care, and Pet Insurance. Flexible work environment with some remote working opportunities Strong fun and teamwork environment Learning, development, and career growth
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At this time, we are unable to consider candidates requiring visa sponsorship or third-party recruitment agencies for this role. We encourage all applicants to apply directly, and we thank you for your understanding.
Apply now, read the job details by scrolling down Double check you have the necessary skills before sending an application. Overview: 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 Abbott 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.
Location: Onsite - Maple Grove, MN or St Paul, MN (must be local to MN)
Responsibilities:
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
Required Qualifications:
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
Preferred 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)
Benefits: York Solutions Offers a generous benefits package for eligible full-time employees: BCBS Medical with 3 Plans to choose from (PPO and High deductible PPO plans with Health Savings Program) Delta Dental plan with 2 free cleanings and insurance discounts Eye Med Vision with annual check-ups and discounts on lens Life and Accidental Death Insurance paid by company John Hancock 401(k) Retirement Plan with discretionary company match up to 5% Voluntary Insurance programs such as: Hospital Indemnity, Identity Protection, Legal Insurance, Long Term Care, and Pet Insurance. Flexible work environment with some remote working opportunities Strong fun and teamwork environment Learning, development, and career growth
#J-18808-Ljbffr