- Highmark Health (St. Paul, MN)
- …team of specialists. Identify, develop, coordinate, and implement legislative, regulatory , sub- regulatory , and licensing / accreditation requirements.Perform ... ongoing monitoring and analysis of external regulatory and industry intelligence, collaborating with impacted stakeholders, and providing regular, executive… more
- Abbott (Plymouth, MN)
- …allowing people to restore their health and get on with their lives. As the Senior Design Assurance Engineer, you will represent Design Assurance on ... external standards + Ensure DHF content completion, integrity, and regulatory and standards compliance; collaboratively communicating and resolving gaps...as FDA and ISO as it relates to design assurance + Ability to work both within a team,… more
- LCI-Lawinger Consulting (Minneapolis, MN)
- Job Title: Senior / Principal Design Assurance Engineer Location: Minneapolis, MN Job Type: Direct Hire Position Overview: We are seeking an experienced ... Senior Design Assurance Engineer in the Minneapolis...design history file maintenance. + Work closely with quality assurance , regulatory , and manufacturing teams to ensure… more
- Abbott (Plymouth, MN)
- …health and get on with their lives. **The Opportunity** We are recruiting for a ** Senior Regulatory Affairs Specialist** to join our team on-site in our St. Paul ... regulatory approvals and identify and resolve problems. You will provide regulatory guidance to cross-functional partners in support of various programs.… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- …the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Abbott (St. Paul, MN)
- …Abbott and externally. The individual may comment on changing regulations and guidance , interface with outside regulatory agencies and trade associations and ... approval to produce and market new products. + Provides guidance on regulatory requirements and strategies to...(eg, medical products, nutritionals). + 5-7 years' experience in regulatory preferred but may consider quality assurance ,… more
- HNTB (Minneapolis, MN)
- …looking for a rewarding and challenging opportunity? We are seeking a dynamic Senior Environmental Planner to join our growing Minneapolis planning team. This role ... shape a new planning group within HNTB. As a senior member of our team, you will have the...the technical production of planning assignments and teams, providing guidance and direction to early-career staff. Additionally, you'll coordinate… more
- Lumen (St. Paul, MN)
- …manager to bolster and drive our compliance programs. Reporting to the Senior Director Security for GRC and Business Enablement, the information Security Governance ... our external and internal obligations. This role will be expected to provide guidance and make determinations relevant on controls that govern the steps, methods, or… more
- Prime Therapeutics (St. Paul, MN)
- …It fuels our passion and drives every decision we make. **Job Posting Title** Senior Internal Auditor - Remote **Job Description** The Senior Internal Auditor ... fostering strong cross-functional relationships and delivering risk-based insights, the Senior Internal Auditor helps drive informed decision-making and support… more
- Edwards Lifesciences (St. Paul, MN)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... and be part of our inspiring journey. As the ** Senior Specialist, Commercial Clinical Imaging** , you will be...and other imaging modality acquisition and interpretation and provide guidance on case planning strategy execution. + Responsible for… more
- Cardinal Health (St. Paul, MN)
- …on those requirements. + Uphold quality standards that adhere to company, regulatory , and HIPAA policies and procedures. + Collaborate across various functions, ... skills with a proven ability to develop and execute effective quality assurance programs. + Works independently within established procedures; may receive general … more
- The Cigna Group (Bloomington, MN)
- …standards, methodologies, and processes to ensure high-quality outcomes. Rigorous quality assurance processes will be maintained to uphold the highest standards of ... integral to this role. You will act as a mentor to team members, providing guidance and support to help them develop their skills and advance their careers. Building… more
- HNTB (Minneapolis, MN)
- …approach and appropriate production rates. + Oversees and provides quality control/ assurance for quantity takeoffs and cost estimates on complex projects and ... to ensure the project estimate meets all financial and regulatory guidelines. Prepares bid estimates for use in reviewing...data use on programs across all projects. + Provides guidance and oversight of the use of estimating software,… more
- Bausch + Lomb (St. Paul, MN)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance , Pharmacovigilance/GPSS and Drug/Device ... completion of clinical studies according to applicable regulations and guidance , ICH and GCP, and Bausch & Lomb SOPs...are being met and provide the operations director and/or senior management with timely updates on progress and changes… more
- Medtronic (Minneapolis, MN)
- …quality assurance , including conducting audits and ensuring compliance with regulatory standards. + Knowledge of Regulatory Requirements: A deep ... Life** In this exciting role as a member of Medtronic Clinical and Regulatory Solutions (MCRS) Quality Audit team, the Principal Clinical Quality Specialist - Audit… more
- Cardinal Health (Roseville, MN)
- …and processes to ensure products and services comply with regulatory standards and specifications. Quality Management provides strategic oversight, leadership ... the United States. + Is responsible for all Quality Assurance functions including but not limited to: raw material...protocols and site related records management. + Provides advice, guidance and training to QA staff in the verification… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... complements that of the Global Quality function. The leader shall provide guidance , strategic direction, and leadership to the Global Quality function with… more
- City National Bank (St. Paul, MN)
- …processes to comply with vendor management / third party risk management related regulatory requirements, guidance and oversight (OCC 2013-29, Fed SR 13-19 or ... and quarterly status reporting, key supplier metrics and periodic updates to senior business leadership on supplier risks 5. Effectively communicate and partner with… more
- Prime Therapeutics (St. Paul, MN)
- …decision we make. **Job Posting Title** MTM Specialist Sr **Job Description** The Senior Medication Therapy Management (MTM) Service Specialist will act as a Subject ... of the MTM programs in addition to assisting the leaders with Quality Assurance , training and daily tasks as needed. **Responsibilities** + Receive inbound and make… more
- Evolent (St. Paul, MN)
- …decision-making. + Act as a key resource for Initial Clinical Reviewers, offering guidance and expertise to ensure the application of best practices. + Provides ... with requesting physicians or ordering providers, when available, within the regulatory timeframe of the request. + Utilizes medical/clinical review guidelines and… more