- Create and manage Technical Files in compliance with IVDD and IVDR.
- Review Protocols, data and write reports to support regulatory submissions.
- Support FDA submission applications for new IVD products.
- Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.
- Be involved in cross-functional projects contributing to problem solving and continuous improvement initiatives.
- Bachelor's Degree with 2 years of experience in Life Sciences/Similar fields or a Master's degree
- Excellent written and communication skills.
- Ability to work in a very busy environment and to manage change effectively.
- Knowledge of FDA, registrations and commercialization of medical devices.
- Demonstrated knowledge and understanding of global regulations and guidelines governing in-vitro diagnostics.
- RAC certificate
- IVDR regulations knowledge
-
Regulatory Affairs Analyst II
3 weeks ago
Beckman Coulter Chaska, United StatesWondering what's within Beckman Coulter? Take a closer look. · At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and a ...
-
Regulatory Affairs Analyst II
1 month ago
Danaher Chaska, United States Full timeWondering what's within Beckman Coulter? Take a closer look. · At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and al ...
-
Regulatory Affairs Analyst
2 weeks ago
UnitedHealth Group Minneapolis, United StatesAt UnitedHealthcare, we're simplifying the health care experience, creating healthier communities and removing barriers to quality care. The work you do here impacts the lives of millions of people for the better. Come build the health care system of tomorrow, making it more resp ...
-
Regulatory Affairs Analyst
1 week ago
Threadneedle group Minneapolis, United StatesWe have an exciting opportunity at Ameriprise as a Regulatory Affairs Analyst This position is part of a team that provides day-to-day operational support to the Regulatory Affairs team in managing regulatory exams, inquiries and internal investigations. This includes matter inta ...
-
Regulatory Affairs Analyst
1 week ago
Ameriprise Financial Minneapolis, United StatesWe have an exciting opportunity at Ameriprise as a Regulatory Affairs Analyst This position is part of a team that provides day-to-day operational support to the Regulatory Affairs team in managing regulatory exams, inquiries and internal investigations. This includes matter inta ...
-
Senior Regulatory Affairs Analyst
3 weeks ago
UnitedHealth Group Minnetonka, United StatesSpecifically, this position will support the Surest large group work required from a regulatory perspective. You will partner with legal and compliance Responsibilities include aligning with the business to: Prepare filings for submission through SER Regulatory Affairs, Analyst, ...
-
Regulatory Affairs Analyst
2 weeks ago
UnitedHealth Group Minneapolis, United StatesRespond to inquiries, requests and actions by regulators, including complaints and requests for assistance Complete internal regulatory review and filings related to marketing materials and policy forms Handle other regulatory research, report genera Regulatory Affairs, Regulator ...
-
Quality Systems Analyst- St. Paul, MN
1 day ago
MGC Diagnostics Saint Paul, United StatesAre 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 ( is a leader in providing innovative ...
-
Financial Aid Business Analyst
3 weeks ago
Indiana University Bloomington Bloomington, United States Full timeJob Summary · As a Financial Aid Business Analyst on the IA Compliance and Reporting team, the incumbent will be responsible for the following: · Department-Specific Responsibilities · Leverages knowledge of financial aid policies and processes, other student data, and financia ...
-
Compliance Analyst
1 week ago
NOVON Consulting Corp. Minneapolis, United StatesAbout the job Compliance Analyst · Contract-to-hire role · Hybrid onsite/Minneapolis · W2/USC only · Compliance Analyst · Licenses SIE, Series 7TO, Series 63, Series 24 (Series 16, 86/87, 57 also a plus but not required) · Experience minimum of 3 years Compliance/Supervisor ...
-
Clinical Data Systems Analyst II
1 week ago
Abbott Laboratories Maple Grove, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
Events Project Coordinator
6 days ago
University of Minnesota Minneapolis, United States1145 jobs found. Only the first 300 jobs can be displayed. · Search Results List · 300 rows List View · Grid View Job Title · Job ID · Location · Department · Posted Date · Job Title Assistant Professor and Director of Experimental Surgical Services · Job ID 361897 · Locatio ...
-
Regional Director
2 weeks ago
Lutheran Social Service of Minnesota Rosemount, United StatesLutheran Social Service of Minnesota is a dynamic social service organization serving children, youth and families, people with disabilities, older adults, and military veterans. Trustworthiness is a value and strength shared by our employees and recognized by the communities we ...
-
Senior Network Access Analyst
1 week ago
Surescripts Minneapolis, United StatesSurescripts serves the nation through simpler, trusted health intelligence sharing, in order to increase patient safety, lower costs and ensure quality care. We deliver insights at critical points of care for better decisions - from streamlining prior authorizations to delivering ...
-
Product Software Engineer
1 day ago
Capgemini Minneapolis, United StatesProduct Software Engineer - Sr. Software Test Engineer · Job location: Minneapolis, Minnesota · Job description: · Capgemini is in search of a highly skilled and motivated Product Software Engineer - Sr. Software Test Engineer to become a valued member of our extraordinary engine ...
-
Director of Lending
1 week ago
Minnesota Council of Nonprofits Minneapolis, United StatesJob Summary · The African Development Center is seeking a Director of Lending / Business Development to join our team. The · Director of Lending / Business Development · is responsible for managing and servicing a portfolio of existing businesses, while actively engaging prosp ...
-
Director of Lending
2 weeks ago
Minnesota Council of Nonprofits Minneapolis, United StatesJob Summary · The African Development Center is seeking a Director of Lending / Business Development to join our team. The · Director of Lending / Business Development · is responsible for managing and servicing a portfolio of existing businesses, while actively engaging prospe ...
-
Compliance Analyst
3 weeks ago
NOVON Consulting Corp. Minneapolis, United StatesAbout the job Compliance Analyst · Contract-to-hire role · Hybrid onsite/Minneapolis · W2/USC only · Compliance Analyst · Licenses SIE, Series 7TO, Series 63, Series 24 (Series 16, 86/87, 57 also a plus but not required) · Experience minimum of 3 years Compliance/Supervisory ...
-
Manager, Medical Affairs
3 weeks ago
Abbott Laboratories company Minneapolis, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
Commercial Banker
3 weeks ago
Merchants Bank Lakeville, United StatesMerchants Bank is a growing, employee-owned company, dedicated to a philosophy of community banking and giving excellent customer service. We are searching for a · Commercial Banker · in the · Lakeville, Minnesota · area market. · The Commercial Banker is responsible for the ...
Regulatory Affairs Analyst II - Chaska, United States - Danaher Corporation
Description
Wondering what's within Beckman Coulter? Take a closer look.At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward.
Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates.Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challengesThe Regulatory Affairs Analyst II at Beckman Coulter Diagnostics is a subject-matter expert responsible for creating and managing regulatory documentation for new product development.
They manage regulatory initiatives, collaborate with third parties, produce technical documentation, assist with global product commercialization, support multiple projects, and work closely with the team to build consensus and champion regulatory initiatives throughout the project lifecycle.
This position is part of the regulatory affairs dept. located in Chaska, MN and will be hybrid. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.You will be a part of the Immunoassay Regulatory Affairs team and report to the Senior Manager of Regulatory Affairs.
If you thrive in a fast-paced role and want to contribute to a world-class Regulatory Affairs organization—read onIn this role, you will have the opportunity to:
This is also a plus:
We recognize the benefits of flexible, working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement.
This position is eligible for an on-site work arrangement which is defined as being on-site a minimum of 3 days each week.
The other 2 days can be on-site or remotely from your home. Additional information about this work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.#LI-NS3
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology.
We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visitDanaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.
Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here ) .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.
Please contact us at to request accommodation.
