Regulatory Affairs Specialist jobs in Minnesota
Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Specialist jobs
Senior Regulatory Affairs Specialist
- ICONMA, LLC
-
Saint Paul, MN
FULL_TIME
-
This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
Identify opportunity for regulatory affair processes and drive changes to completion.
Perform assigned regulatory activities including submissions/responses to country authorities.
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.
Requirements
Have working knowledge in EU MDR.
Have working knowledge in Regulatory Change Assessment.
Have working knowledge in US and EU medical device submissions.
Have experience supporting internal and external inspections.
Work cross-functionally and in a matrixed environment.
Have experience with continuous improvement activities.
BA Degree Required.
3-5 years experiences in Medical Device Regulatory Affairs.
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.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
- 10 Days Ago
Regulatory Affairs Specialist
- USA 3M Company
-
Minnesota, MN
FULL_TIME
- Job Description: Regulatory Affairs Specialist Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life...
- 14 Days Ago
Regulatory Affairs Specialist
- Medtronic
-
Rice, MN
FULL_TIME
- Careers that Change Lives Medtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulator to treat chronic pain and engineered the first deep brain stimul...
- 3 Days Ago
Regulatory Affairs Specialist II
- Laborie Medical Technologies Corp
-
Minnetonka, MN
FULL_TIME
- We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready...
- 6 Days Ago
Regulatory Affairs Specialist
- St. Croix Hospice
-
OAKDALE, MN
OTHER
- Job Details Job Location: Administration - OAKDALE, MN Position Type: Full Time Salary Range: Undisclosed DescriptionThe Regulatory Affairs Specialist is responsible for assisting the St. Croix Hospic...
- 8 Days Ago
Principal Regulatory Affairs Specialist
- Synergy Solutions
-
Saint Paul, MN
CONTRACTOR
- 24 month contract with possible conversion to permanent employment after 1 year if desired. Work is onsite w/ hybrid opportunity out of Moundsview MN- must reside within commutable distance. Directs o...
- 25 Days Ago
Regulatory Affairs Specialist jobs at Popular Companies
Regulatory Affairs Specialist
- DivIHN Integration Inc
-
Green Oaks, IL
- DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, C...
- 4/19/2024 12:00:00 AM
Regulatory Affairs Specialist
- Johnson & Johnson
-
Danvers, MA
- Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Regulatory Affairs Specialist. Remote work options may...
- 4/19/2024 12:00:00 AM
Regulatory Affairs Specialist
- Adecco Staffing, USA
-
San Diego, CA
- Regulatory Affairs Specialist Full Time San Diego, CA, US Salary Range: $90,000.00 To 110,000.00 Annually Monday - Frida...
- 4/19/2024 12:00:00 AM
Regulatory Affairs Specialist
- Morair Medtech, LLC
-
Seattle, WA
- Morair Medtech, LLC is at the forefront of medical technology, specializing in endobronchial treatments for lung disease...
- 4/18/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 4/17/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Lake Forest, IL
- Regulatory Affairs Specialist – Onsite in Lake Forest, IL Must be able to work W2 Summary Our client, a Fortune-500 Medi...
- 4/16/2024 12:00:00 AM
Regulatory Affairs Specialist
- Planet Pharma
-
- Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
- 4/16/2024 12:00:00 AM
Regulatory Affairs Specialist
- Spectraforce
-
North Chicago, IL
- Job Title: Specialist Regulatory Affairs, Pacific Asia Location: North Chicago, IL 60064 Duration: 7+ Months Min pay rat...
- 4/15/2024 12:00:00 AM
About Minnesota
Minnesota (/ˌmɪnɪˈsoʊtə/ (listen)) is a state in the Upper Midwest and northern regions of the United States. Minnesota was admitted as the 32nd U.S. state on May 11, 1858, created from the eastern half of the Minnesota Territory. The state has a large number of lakes, and is known by the slogan the "Land of 10,000 Lakes". Its official motto is L'Étoile du Nord (French: Star of the North).
Minnesota is the 12th largest in area and the 22nd most populous of the U.S. states; nearly 60% of its residents live in the Minneapolis–Saint Paul metropolitan area (known as the "Twin Cities"). This area i...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$77,701 to $104,132
Most Popular Cities in Minnesota for Regulatory Affairs Specialist Jobs
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Petaluma, CA
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019