Regulatory Operations Compliance Project Manager – Medical Devices
Abbott
full-time
Posted on:
Location Type: Office
Location: Maple Grove • Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $97,300 - $194,700 per year
Job Level
JuniorMid-Level
About the role
- Lead Regulatory process/procedure updates
- Implement emerging regulation requirements into Regulatory documentation with alignment with Abbott cross BU/ cross functional teams
- Develop and/or author new regulatory policies, processes and SOPs
- Facilitate procedure implementation
- Provide strategic input and technical guidance on regulatory requirements for process decisions
- Evaluate regulatory risks of division policies, processes, procedures
- Develop and mentor regulatory professionals
- Drive change order activities
- Create supplemental training materials
- Review and follow document quality system structure
- Lead team meetings and document meeting minutes
- Work on process workflow development teams collaborating with Abbott IT system enhancement teams
- Author communications and presentations for upper management
Requirements
- 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
- Bachelor's Degree in a related field OR an equivalent combination of education and work experience
- Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals)
- Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences
- Domestic and international regulatory guidelines, policies and regulations
- Lead functional groups in the development of relevant data to complete a regulatory submission
Benefits
- free medical coverage in Health Investment Plan (HIP) PPO medical plan
- excellent retirement savings plan with high employer contribution
- tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory documentationregulatory policiesSOPsregulatory requirementsregulatory risksprocess workflow developmentchange order activitiestraining materials developmentdocument quality systemregulatory submission
Soft skills
strategic inputtechnical guidancementoringcommunicationcollaborationleadershipnegotiationteam meetings facilitationpresentation skillsdocumenting meeting minutes