Senior Regulatory Affairs Specialist

4 weeks ago


Saint Paul, United States Collabera Full time
Job DescriptionJob Description

·         Perform assigned regulatory activities including submissions/responses to country authorities.

 

Daily Responsibilities - Job Description suppliers should use:

·         Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review.

·         Assist in strategy implementation and operations for regulatory affairs activities, including development of EU MDR Technical File submissions and responses to Notified Bodies.

·         Assist in maintaining Regulatory records and files.

·         Review product changes as assigned and assess required EU MDR submissions/notifications.

 

Educational Requirements:

·         BA Degree required, preferably in a science, engineering or technology discipline.

·         Work Experience Requirements: 3-5 years experiences in Medical Device Regulatory Affairs Top

 

Skills:

·         Strong oral communication and interpersonal skills

·         Proficient in technical writing

·         Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously.

·         MS Office Suite including an Intermediate level with Excel using Pivot Tables, Creating Trackers in Excel and monitoring these/Conditional Formatting.

 

Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.

  • St Paul, United States Barrington James Full time

    Senior Manager Regulatory Affairs - (Medical Device) - Hybrid in MN Our client is an, looking for a Senior Manager Regulatory Affairs with extensive experience with 510(k) submissions. As the Senior Manager Regulatory Affairs you will be the liaison for communication with US and international regulatory agencies for multiple submissions across the company....


  • Saint Paul, Minnesota, United States Insight Global Full time

    Location: St. Paul, MN - remote to start, but will transition to a hybrid model in the coming monthsContract: 3-12 month contract to likely hirePay: $ /hrOpenings: 1Must-haves Bachelors Degree in chemistry, biology, or other scientific/technical disciplineDatabase management skillsVery detail orientedExcellent written and verbal communication...


  • St Paul, United States Insight Global Full time

    Location: St. Paul, MN - remote to start, but will transition to a hybrid model in the coming monthsContract: 3-12 month contract to likely hirePay: $ /hrOpenings: 1Must-haves Bachelors Degree in chemistry, biology, or other scientific/technical disciplineDatabase management skillsVery detail orientedExcellent written and verbal communication...


  • St Paul, United States Hemostasis Corp Full time

    Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, wound healing technologies, and advanced medical devices for use in the healthcare industry. We are currently seeking a Regulatory Affairs Specialist that will be able to ensure compliance with regulations. Responsibilities Include: Communicate with regulatory agencies regarding...


  • St Paul, United States Collabera Full time

    Job Description Job Description · Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - Job Description suppliers should use: · Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review. · Assist in...


  • St Paul, United States PAREXEL Full time

    Bring your regulatory expertise and passion for combination products to Parexel! Excellent opportunity for a “cradle to crypt” Medical Device Regulatory professional to share their expertise with multiple clients with innovative technologies! Parexel’s incredible Regulatory Consulting team is currently seeking a Combination Product Senior Regulatory...


  • St Paul, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle. This role is...


  • Saint Paul, Minnesota, United States ECOLAB Full time

    Pharma and Personal Care - Regulatory Affairs Manager/ NA Regulatory Business PartnerAt Ecolab, making the world a cleaner, safer place is our business. In our Pharmaceutical & Personal Care (PPC) division, we are committed to providing complete solutions for the Pharma & Personal Care Industries.Ecolab is a company committed to growth and we believe that...


  • Saint Paul, United States Bell International Laboratories, Inc Full time

    Job DescriptionJob DescriptionDescription:Position Summary:The Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring...


  • Saint Petersburg, United States Allogene Therapeutics Full time

    Job Description About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is...


  • St Paul, United States Bell International Laboratories Full time

    The Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory requirements. Make sure...

  • Regulatory Specialist

    2 weeks ago


    St Paul, United States Bell International Laboratories Full time

    The Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory...

  • Regulatory Specialist

    2 weeks ago


    St Paul, United States Bell International Laboratories Full time

    The Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory...


  • St Paul, United States Bell International Laboratories Full time

    The Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory requirements....


  • Saint Louis, MO, United States Kindeva Drug Delivery Full time

    Associate Director of Regulatory Affairs Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. Look no further, we are hiring for a Associate Director of Regulatory Affairs at our St. Experienced CMC professional serving as project...


  • Saint Louis, MO, United States Kindeva Drug Delivery Full time

    Associate Director of Regulatory Affairs St. Louis, MO, USA Req #972 Monday, May 20, 2024 Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as...


  • St. Paul, United States ECOLAB Full time

    Pharma and Personal Care - Regulatory Affairs Manager/ NA Regulatory Business Partner At Ecolab, making the world a cleaner, safer place is our business. In our Pharmaceutical & Personal Care (PPC) division, we are committed to providing complete solutions for the Pharma & Personal Care Industries. Ecolab is a company committed to growth and we believe that...


  • St Paul, United States MGC Diagnostics Full time

    Are you looking for an opportunity to grow where your experience matters? Do you strive for a career with meaning and purpose? If you thrive in a fast-paced environment and want to work with a great team, we might be a fit! MGC Diagnostics (www.MGCDiagnostics.com) is a leader in providing innovative technology for cardio-respiratory diagnostics. We recognize...


  • St Paul, United States MGC Diagnostics Full time

    Are you looking for an opportunity to grow where your experience matters? Do you strive for a career with meaning and purpose? If you thrive in a fast-paced environment and want to work with a great team, we might be a fit! MGC Diagnostics (www.MGCDiagnostics.com) is a leader in providing innovative technology for cardio-respiratory diagnostics. We recognize...


  • St Paul, United States MGC Diagnostics Full time

    Are you looking for an opportunity to grow where your experience matters? Do you strive for a career with meaning and purpose? If you thrive in a fast-paced environment and want to work with a great team, we might be a fit! MGC Diagnostics (www.MGCDiagnostics.com) is a leader in providing innovative technology for cardio-respiratory diagnostics. We...