- Abbott (St. Paul, MN)
- …aligned with global business objectives. + Collaborate with internal stakeholders ( Regulatory , Clinical, Quality , Operations, Marketing) and external partners ... devices. + **Cross-Functional Collaboration** : Skilled in partnering across Clinical, Regulatory , Quality , Operations, Marketing, and Legal to drive integrated… more
- Danaher Corporation (Chaska, MN)
- …, and train new team members as needed. + Ability to assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO ... and escalate as necessary. + Identify, recommend, and implement quality improvements. Learn and participate in the company's lean...regulatory requirements by completing appropriate paperwork, maintaining accurate records… more
- Danaher Corporation (Chaska, MN)
- …, and train new team members as needed. + Ability to assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO ... issues and escalate as necessary. + Identify and recommend quality improvements. Learn and participate in the company's lean...regulatory requirements by completing appropriate paperwork , maintaining accurate… more
- United Therapeutics (Stewartville, MN)
- …all SOPs and quality assurance standards. + Directly interact with internal Quality and regulatory agencies during inspections + Perform other duties as ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- Medtronic (Minneapolis, MN)
- …for implantable medical device systems that align with customer expectations, regulatory standards, and business objectives. + Ensure the systematic conversion of ... Engineering knowledge and processes. + Champion consistent implementation of the Quality System across projects. **TECHNICAL SPECIALIST CAREER STREAM** An individual… more
- Medtronic (Fridley, MN)
- …Code Development, Testing, and Validation, ensuring systems meet both technical specifications and regulatory standards (eg, FDA , 21 CFR Part 11). You'll work ... closely with cross-functional engineering, quality , and manufacturing teams to standardize equipment control systems, troubleshoot both custom and off-the-shelf… more
- Actalent (Burnsville, MN)
- …and FDA regulations related to the pharmaceutical industry * Experience with FDA and other regulatory agencies required * Bachelors degree in science ... products. Serves as a technical expert that supports product improvements, quality improvements, customer requests, and cost savings initiatives. Is responsible for… more
- Bausch + Lomb (St. Paul, MN)
- …role combines PRC process leadership with editorial oversight to ensure compliance, quality , and timeliness across all materials reviewed through the Bausch + Lomb ... Marketing Operations is responsible for verifying that Legal, Medical, and Regulatory feedback has been accurately implemented into Bausch + Lomb promotional… more
- Abbott (Maple Grove, MN)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with...+ Remains current on developments in field(s) of expertise, regulatory requirements, and industry trends and trains staff regarding… more
- Teleflex (Plymouth, MN)
- …and validation testing, drawings, calculation and/or FMEA * Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans ... medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in… more