Regulatory Affairs Manager

2 days ago


Eagan, Minnesota, United States Compass Consulting Full time
Job Summary

This position plays a critical role in ensuring the Company's medical device products and processes meet regulatory requirements. The successful candidate will be responsible for maintaining ISO 13485 Certification, ensuring FDA and Health Canada compliance, and managing CE Mark status.

Key Responsibilities
  • Collaborate with engineering, product management, suppliers, and staff to ensure product quality and compliance.
  • Develop and maintain documentation to support regulatory submissions and audits.
  • Manage the quality system, including CAPA, internal and external audits, and continuous improvement initiatives.
  • Coordinate training and awareness programs for the quality management system.
  • Support the Design Control and Risk Management process.
  • Manage inventory control and flow.
Requirements
  • Strong knowledge of regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Ability to advocate product excellence and quality.
  • Proven track record of meeting deadlines and responding to urgent needs.
  • Experience with validation testing methodologies and performance characterization.
  • Bachelor's degree in biomedical, mechanical, chemical, or electrical engineering preferred.
  • Experience with Grand Avenue Software required.
  • Experience with NetSuite or similar software preferred.


  • Eagan, Minnesota, United States Bell International Laboratories Full time

    Job OverviewAs the Manager of Quality Systems, you will spearhead and oversee the Quality Systems division, collaborating closely with the Vice President of Quality and Regulatory Compliance on all matters related to quality, regulatory standards, and compliance. This position is crucial in maintaining cGMP compliance during audits conducted by regulatory...

  • Pharmacy Manager

    2 weeks ago


    Eagan, Minnesota, United States Walgreens Full time

    Job SummaryWalgreens is seeking a highly skilled Pharmacy Manager to lead our pharmacy team in delivering exceptional patient care and services. As a Pharmacy Manager, you will be responsible for overseeing the daily operations of the pharmacy, ensuring compliance with regulatory requirements, and driving business growth through strategic initiatives.Key...


  • Eagan, Minnesota, United States Bell International Laboratories Full time

    Job SummaryBell International Laboratories is seeking a highly skilled Program Manager to lead the Commercial and Research and Development stability programs. The ideal candidate will be responsible for the execution of the stability program, which includes initiating stability protocols, scheduling stability inventories, coordinating stability pulls,...


  • Eagan, Minnesota, United States Sanimax Full time

    Job Summary: Sanimax is seeking an experienced Transportation Manager to oversee and optimize our transportation operations. The ideal candidate will have a strong background in transportation management, with a focus on efficiency, cost-effectiveness, and leading and developing people. As a Transportation Manager at Sanimax, you will be responsible for...


  • Eagan, Minnesota, United States Sanimax Full time

    Your professional journey starts hereAre you passionate about building a sustainable future and driving business growth? Do you have a strong background in transportation management and a passion for leading and developing high-performing teams?This role is for youJob Summary: Sanimax is seeking an experienced Transportation Manager to oversee and optimize...

  • Operations Manager

    3 weeks ago


    Eagan, Minnesota, United States Jiffy Lube Full time

    About the RoleWe are seeking a highly motivated and experienced Assistant General Manager to join our team at Jiffy Lube. As a key member of our management team, you will be responsible for driving sales growth, delivering exceptional customer experiences, and leading a high-performing team.Key ResponsibilitiesWork closely with the General Manager to develop...


  • Eagan, Minnesota, United States Jiffy Lube Full time

    About the RoleWe are seeking a highly motivated and experienced Assistant General Manager to join our team at Jiffy Lube. As a key member of our management team, you will be responsible for driving sales growth, delivering exceptional customer experiences, and leading a high-performing team.Key ResponsibilitiesWork closely with the General Manager to develop...


  • Eagan, Minnesota, United States GAIC Great American Insurance Company Full time

    Job SummaryWe are seeking a highly skilled Risk Management Specialist to join our team at GAIC Great American Insurance Company. As a Risk Management Specialist - Surety Bonds, you will be responsible for managing and mitigating risks associated with surety bonds.Key ResponsibilitiesAssess and analyze risk profiles to determine the likelihood of loss or...


  • Eagan, Minnesota, United States Jiffy Lube Full time

    About the RoleWe are seeking a highly motivated and experienced Assistant General Manager to join our team at Jiffy Lube. As a key member of our management team, you will be responsible for driving sales growth, delivering exceptional customer experiences, and leading a high-performing team.Key ResponsibilitiesWork closely with the General Manager to develop...


  • Eagan, Minnesota, United States Creative Financial Staffing Full time

    Accounts Receivable Manager Job DescriptionWe are seeking an experienced Accounts Receivable Manager to oversee and manage the accounts receivable department of our organization.The ideal candidate will have a strong background in accounting principles and practices, as well as excellent leadership and communication skills.Key Responsibilities:Manage and...


  • Eagan, Minnesota, United States Kelly Science, Engineering, Technology & Telecom Full time

    Job SummaryKelly Scientific, a leading provider of scientific, engineering, technology, and telecom solutions, is seeking a highly skilled Compounding Manager to lead our personal care contract manufacturing operations in Eagan, Minnesota.Key ResponsibilitiesOperational Leadership: Oversee the management of compounding, sanitization, and chemical room...

  • RN Case Manager

    9 hours ago


    Eagan, Minnesota, United States Blue Cross Blue Shield of Minnesota Full time

    About Blue Cross Blue Shield of MinnesotaWe're a leading health care provider with 2.5 million members, committed to reinventing health care to improve health for our members and the community.Job SummaryWe're seeking a skilled RN Case Manager to join our team. As a RN Case Manager, you will research and analyze member health needs and healthcare cost...


  • Eagan, Minnesota, United States Creative Financial Staffing Full time

    Job SummaryWe are seeking an experienced Senior Financial Manager to oversee and manage the accounts receivable department of our organization. The ideal candidate will have a strong background in financial management principles and practices, as well as excellent leadership and communication skills.Key ResponsibilitiesManage and oversee the daily operations...


  • Eagan, Minnesota, United States Blue Cross and Blue Shield of Minnesota Full time

    About Blue Cross and Blue Shield of MinnesotaWe are a leading health care organization with 2.5 million members, committed to reinventing health care to improve health for our members and the community.Key ResponsibilitiesThe Director of Utilization Management and Operations will lead and direct the utilization review team, ensuring policies and procedures...


  • Eagan, Minnesota, United States Granite City Food & Brewery Full time

    About the RoleWe are seeking a highly skilled and experienced Executive Chef to join our team at Granite City Food & Brewery. As a key member of our culinary team, you will be responsible for delivering exceptional dining experiences to our guests.Key Responsibilities:Lead a high-performing kitchen team, ensuring seamless execution of menu items and...


  • Eagan, Minnesota, United States Creative Financial Staffing Full time

    Job SummaryWe are seeking an experienced Senior Financial Manager to oversee and manage the accounts receivable department of our organization. The ideal candidate will have a strong background in financial principles and practices, as well as excellent leadership and communication skills.Key ResponsibilitiesManage and oversee the daily operations of the...


  • Eagan, Minnesota, United States Blue Cross and Blue Shield of Minnesota Full time

    About Blue Cross and Blue Shield of MinnesotaWe are a leading health care brand with 2.5 million members, committed to reinventing health care to improve health for our members and the community.Job SummaryThe Director of Utilization Management leads and directs the utilization review team, ensuring policies and procedures incorporate best practices and...


  • Eagan, Minnesota, United States Blue Cross and Blue Shield of Minnesota Full time

    About Blue Cross and Blue Shield of MinnesotaBlue Cross and Blue Shield of Minnesota is a leading health care organization with a strong commitment to improving health outcomes for its members and the community. With a rich history of innovation and excellence, we strive to be a trusted partner in the pursuit of better health.Job SummaryThe Director of...


  • Eagan, Minnesota, United States C4 Technical Services Full time

    Job SummaryC4 Technical Services is seeking a highly skilled Information Security Analyst to join our team. As a key member of our security team, you will be responsible for ensuring the confidentiality, integrity, and availability of our clients' sensitive information.Key ResponsibilitiesConduct thorough risk assessments and develop mitigation plans to...


  • Eagan, Minnesota, United States Clean Harbors Full time

    About the RoleClean Harbors, a leading provider of environmental, energy, and industrial services, is seeking a skilled Environmental Services Technician to join our team. As a key member of our operations team, you will be responsible for providing comprehensive environmental services, including collection and disposal of damaged, discarded, or recalled...