What are the responsibilities and job description for the Global Regulatory Services Quality Compliance Project Lead - GRS-QC Project Lead position at Equiliem?
Job Details
Global Regulatory Services Quality Compliance Project Lead - GRS-QC Project Lead
Job Description:
The Global Regulatory Services 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: Vascular, Neuromodulation, Structural Heart, Electrophysiology, Cardiac Rhythm Management, Heart Failure. 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 Manager. They will work with the cross-business unit RA harmonization 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:
RA QA experience desired:
Qualifications/Skills desired
About Equiliem
Equiliem believes in empowering success. It's our job to cultivate relationships that connect people and employers in a way that is inclusive, intelligent, and allows both to thrive.
Across the U.S., leading companies in healthcare, government, engineering, manufacturing, professional services, and energy rely on us for their workforce solutions. Our recruiting and HR services include contract and direct hire staffing, Payrolling/EOR, Independent Contractor Compliance, and Managed Services.
For almost 30 years, we've helped shape our industry. Today, we continue to research, ask questions, and continuously enhance the candidate journey and client experience.
EEO Employer
Equiliem is an equal opportunity employer. We do not discriminate or allow discrimination based on race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Equiliem will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or .
Job Description:
The Global Regulatory Services 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: Vascular, Neuromodulation, Structural Heart, Electrophysiology, Cardiac Rhythm Management, Heart Failure. 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 Manager. They will work with the cross-business unit RA harmonization 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
- Drive change order activities, supplemental training materials and related implementation activities
- 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
RA QA experience desired:
- Regulatory Change Assessment
- International Product Registration support
- Procedural Writing
- Ad and Promotional Material - Regulatory Review
- Project management skills - organize and host meetings
- Quality System maintenance activities
- Documenting Justification for change from Regulatory perspective
Qualifications/Skills desired
- Bachelor's Degree
- 5 years experience in a regulated industry
- Familiarity with Regulatory Affairs departmental responsibilities and processes
- Independent Problem Solving
- 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
- CAPA experience
- Windchill experience
About Equiliem
Equiliem believes in empowering success. It's our job to cultivate relationships that connect people and employers in a way that is inclusive, intelligent, and allows both to thrive.
Across the U.S., leading companies in healthcare, government, engineering, manufacturing, professional services, and energy rely on us for their workforce solutions. Our recruiting and HR services include contract and direct hire staffing, Payrolling/EOR, Independent Contractor Compliance, and Managed Services.
For almost 30 years, we've helped shape our industry. Today, we continue to research, ask questions, and continuously enhance the candidate journey and client experience.
EEO Employer
Equiliem is an equal opportunity employer. We do not discriminate or allow discrimination based on race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Equiliem will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or .
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