Regulatory Compliance Specialist

2 weeks ago

Saint Paul, Minnesota, United States Scanlan Int'l Full time
Job Overview

POSITION / JOB SUMMARY:

The Compliance Engineer plays a crucial role in overseeing all technical and engineering documentation for assigned projects. This position is responsible for planning and managing technical tasks related to Single-Use Devices and Re-Usable Surgical Instruments, ensuring precision and quality throughout the product lifecycle. The Compliance Engineer will maintain technical documentation for global distribution, including regulatory registrations, and uphold process validations for sterilization, packaging, and reprocessing. Additionally, this role requires leading cross-functional teams and coordinating external resources while developing, organizing, and preserving test plans, protocols, and reports.

Key Responsibilities:

Product Support (50%):

  • Ensure product compliance with US, EU, and international regulatory standards by creating necessary test plans, protocols, and reports.
  • Lead design assurance teams, including engineers specializing in Human Factors, Biocompatibility, Packaging, Risk, Sterilization, and Manufacturing through all stages of product design and development.
  • Oversee sterilization processes to ensure market readiness of products.
  • Drive the development and validation of testing methods in collaboration with the testing team, identifying applicable standards and establishing acceptance criteria.
  • Conduct gap analyses of relevant standards to maintain technical documentation and ensure compliance with current best practices.
  • Manage the Risk Management process, including writing and maintaining risk management plans, assessments, and hazard analyses.
  • Provide engineering support to troubleshoot manufacturing processes in collaboration with production partners.

Quality Systems and Design Control (50%):

  • Coordinate and maintain documentation in alignment with ISO 13485 and FDA 820 quality systems, including essential design control documents.
  • Investigate product complaints and engage in the Corrective Actions/Preventative Action process.
  • Facilitate root cause analysis for quality and clinical issues arising from existing products.

QUALIFICATIONS:

Required Qualifications:

Education:

  • Bachelor's degree in Engineering, Sciences, or a related field.

Experience:

  • Minimum of 5 years of relevant experience in a similar role within a regulated industry, including quality management system experience.
  • Experience in technical review and documentation updates to ensure compliance with quality system requirements.
  • Proven ability to understand and interpret regulations, standards, and laws in a regulated environment.

Skills:

  • Proficient in MS Office Suite (Word, Excel, Outlook, OneNote) and MS Project.
  • Strong verbal and written communication skills, with the ability to effectively engage at various organizational levels.
  • Ability to influence and lead indirectly, even in challenging situations.
  • Self-directed with a strong sense of appropriate review and approval processes.
  • Creative problem-solving skills and original thinking for compliance solutions.
  • Ability to manage multiple tasks simultaneously while adapting to changing priorities.

Preferred Qualifications:

Experience:

  • Experience with packaging and sterilization of single-use devices.
  • Experience in reprocessing of reusable devices.
  • Familiarity with biocompatibility testing.
  • Experience in risk management practices.
  • Knowledge of materials and processes such as stainless steel, titanium, nitinol, and thermal plastics.
  • Experience with CE Mark products.

Skills:

  • Ability to apply statistical methods and tools for process validation and capability development.

  • Regulatory Compliance Specialist

    2 months ago

    Saint Paul, Minnesota, United States Murata Electronics Full time

    Regulatory Compliance SpecialistLocation:US Murata Viosis a global medical device company dedicated to creating a paradigm shift in the way healthcare is delivered. Through the utilization of our internet-of-things medical-grade sensors and virtual patient care services, we plan to lower the cost of healthcare and improve patient outcomes. Murata Viosis...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Saint Paul, Minnesota, United States Abbott Full time

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Abbott. This individual will play a critical role in ensuring the compliance of our medical devices with regulatory requirements worldwide.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with global regulations and...

  • Regulatory Compliance Specialist

    1 week ago

    Saint Paul, Minnesota, United States Scanlan Int'l Full time

    Job OverviewPOSITION / JOB SUMMARY:The Compliance Engineer plays a crucial role in overseeing all technical and engineering documentation for assigned projects. This position is essential for planning and managing technical tasks related to Single-Use Devices and Re-Usable Surgical Instruments, ensuring precision and quality throughout the product lifecycle....

  • Regulatory Compliance Specialist

    2 weeks ago

    Saint Paul, Minnesota, United States Scanlan Int'l Full time

    Job OverviewPOSITION / JOB SUMMARY:The Compliance Engineer at Scanlan Int'l plays a crucial role in overseeing all technical and engineering documentation related to assigned projects. This position involves planning and managing technical tasks for Single-Use Devices and Re-Usable Surgical Instruments, ensuring precision and quality throughout the product...

  • Regulatory Compliance Specialist

    2 weeks ago

    Saint Paul, Minnesota, United States State Of Minnesota Department of Public Safety Full time

    Job OverviewPosition SummaryThis role is designed to provide essential administrative assistance to the Alcohol and Gambling Enforcement Division.Key Responsibilities:Implement the guidelines of Minnesota Statutes 340A and Minnesota Rule 7515 in response to diverse inquiries and requests from clients regarding liquor licensing, enforcement, and...

  • Regulatory Compliance Coordinator

    5 days ago

    Saint Paul, Minnesota, United States Carbon Medical Technologies, Inc Full time

    Job DescriptionJob Summary:The Quality Associate plays a crucial role in ensuring ongoing product compliance with our company's quality management systems and objectives. This position is responsible for supporting quality activities throughout the product lifecycle and participating in cross-functional teams to achieve company goals.Key...

  • Advanced Regulatory Compliance Consultant

    1 week ago

    Saint Paul, Minnesota, United States Travelers Full time

    Who Are We? At Travelers, we prioritize the well-being of our customers, communities, and each other. This commitment has solidified our status as a leading property casualty insurer for over 160 years. Join us to experience a culture driven by innovation and collaboration, where you can truly enjoy your work and workplace. Job Category Actuarial...

  • Hybrid Regulatory Affairs Specialist

    2 weeks ago

    Saint Paul, Minnesota, United States RTA US Full time

    Job OverviewJoin the Scientific Team at RTA US, where we are partnering with a prestigious material science organization seeking a Hybrid Regulatory Affairs Specialist.Key ResponsibilitiesAssist in global regulatory initiativesEnsure product compliance and certificationDraft and revise Safety Data Sheets and other regulatory documentationPerform additional...

  • Roving Compliance Specialist

    3 weeks ago

    Saint Paul, Minnesota, United States CommonBond Communities Full time

    Home is the foundation for everything in life. Since 1971, our model has been about supporting residents in finding stability and achieving their goals. It's why we're more than housing-we combine quality affordable homes with our on-site Advantage Services-because we believe that with the right support and opportunities, all people can thrive. Today, over...

  • Safety and Compliance Specialist

    1 week ago

    Saint Paul, Minnesota, United States Jobot Full time

    About the RoleWe are seeking a highly skilled Safety and Compliance Specialist to join our team at Jobot. As a key member of our Environmental Health and Safety team, you will be responsible for ensuring the safety and well-being of our employees and the public.Key ResponsibilitiesSafety Leadership: Provide guidance and support to team members to ensure...

  • Safety and Compliance Specialist

    1 week ago

    Saint Paul, Minnesota, United States Jobot Full time

    About the RoleWe are seeking a highly skilled Safety and Compliance Specialist to join our team at Jobot. As a key member of our Environmental Health and Safety team, you will be responsible for ensuring the safety and well-being of our employees and the public.Key ResponsibilitiesSafety Leadership: Provide guidance and support to team members to ensure...

  • Lead Regulatory Affairs Specialist

    2 weeks ago

    Saint Paul, Minnesota, United States Travelers Full time

    About Us At Travelers, we prioritize the well-being of our clients, communities, and each other. This commitment has solidified our standing as a premier property casualty insurer for over 160 years. Join our innovative culture that thrives on teamwork and collaboration. Envision a career where you truly enjoy what you do and where you do it. Job...

  • Compliance and Quality Assurance Specialist

    5 days ago

    Saint Paul, Minnesota, United States Riverland Community Health Full time

    Job SummaryRiverland Community Health is seeking a highly skilled Quality and Compliance Manager to join our team. As a key member of our organization, you will play a critical role in ensuring the delivery of high-quality healthcare services to our patients.Key ResponsibilitiesCollaborate with Senior Leadership to develop and implement strategies for...

  • Senior Compliance Specialist

    9 hours ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a leading global healthcare company that provides innovative solutions to improve people's lives. Our diverse portfolio of products and services spans the spectrum of healthcare, including diagnostics, medical devices, nutritionals, and pharmaceuticals.Job SummaryWe are seeking a highly skilled Senior...

  • Quality and Compliance Manager

    5 days ago

    Saint Paul, Minnesota, United States Riverland Community Health Full time

    Job SummaryRiverland Community Health is seeking a highly skilled Quality and Compliance Manager to join our team. As a key member of our organization, you will play a critical role in ensuring the delivery of high-quality healthcare services to our patients.Key ResponsibilitiesCollaborate with Senior Leadership to develop and implement strategies that...

  • Supply Chain Compliance Manager

    2 days ago

    Saint Paul, Minnesota, United States Innovize Full time

    Job DescriptionJob Title: Supply Chain Compliance ManagerDepartment: Quality ManagementReports to: Quality DirectorFLSA Status: Exempt, Full TimeJob Summary: The Supply Chain Compliance Manager is responsible for ensuring that all suppliers and vendors meet the necessary regulatory requirements and industry standards. This includes managing supplier...

  • Senior Compliance Analyst

    1 week ago

    Saint Paul, Minnesota, United States Travelers Full time

    About Us At Travelers, we prioritize the well-being of our clients, communities, and employees. Our commitment to excellence has established us as a leading property casualty insurer for over 160 years. Join our innovative and collaborative culture where you can thrive in your career. Job Category Regulatory Affairs Compensation Overview The...

  • Senior Quality Assurance Specialist

    5 days ago

    Saint Paul, Minnesota, United States Hispanic Technology Executive Council Full time

    About Quality Assurance at Hispanic Technology Executive CouncilOur Quality Assurance team plays a vital role in ensuring that our products and services meet the highest standards of quality and regulatory compliance. As a Senior Quality Assurance Specialist, you will be responsible for developing and implementing quality policies, procedures, and processes...

  • Diagnostic Imaging Specialist

    5 days ago

    Saint Paul, Minnesota, United States K.A. Recruiting Full time

    We are seeking a highly skilled Diagnostic Imaging Specialist to join our team at K.A. Recruiting. As a key member of our team, you will be responsible for performing diagnostic imaging procedures using various modalities, including ultrasound.Key Responsibilities:Perform diagnostic imaging procedures using ultrasound and other modalities to produce...

  • Medication Administration Specialist

    2 weeks ago

    Saint Paul, Minnesota, United States NORTHSTAR BEHAVIORAL HEALTH NETWORK LLC Full time

    Become a Vital Part of Our Team as a Medication Administration SpecialistNORTHSTAR BEHAVIORAL HEALTH NETWORK LLC is seeking a dedicated Medication Administration Specialist to enhance our team. In this role, you will play a crucial part in supporting our clients and ensuring they receive the necessary care and assistance.Position Overview:Stay Informed: Keep...