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
Regulatory Affairs Specialist
- Medtronic
-
Fridley, 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 stimulation (DBS) system to treat movement disorders and the first implantable drug pump to deliver medication directly to the intrathecal space of the spine. More than 40 years later, we continue to innovate, constantly challenging ourselves to disrupt the markets we created. We advance science by thinking and acting boldly, bringing together the right people with the right breadth of expertise to engineer groundbreaking therapies and technologies.
Pelvic Health is part of the Neuroscience Portfolio. Our therapies treat patients suffering from overactive bladder, non-obstructive urinary retention, and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally, and personally because of their condition. Our goal is to expand access to our therapies so we can help potentially millions of people get their lives back .
A Day in the Life
Responsibilities may include the following and other duties may be assigned.- Provide regulatory support for currently marketed products. This includes reviewing changes to existing devices and documentation and recommending strategies for the earliest possible approval for regulatory change submissions. Prepare submissions and reports for regulatory agencies as required.
- Leads or compiles all materials required for FDA Annual Reports, EU Technical Documentation updates, annual certificate submissions, and recertification submissions.
- Assist team members by coordinating and preparing document packages for regulatory submissions from multiple functions for new products.
- Assists team members in supporting worldwide licenses and registrations as needed.
- Monitors and improves tracking/control systems.
- Keeps abreast of regulatory procedures, regulatory guidance, and regulations.
- May direct interaction with regulatory agencies on defined matters.
- Bachelor's degree required
- Minimum of 2 years of regulatory affairs experience
- Experience working in a regulated biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and TUV), and working with cross-functional project teams.
- In depth experience with FDA requirements, guidance documents, Active Medical Device Directive, European Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- Experience with Class III medical devices (PMA)
- Strong negotiation skills and written/oral communication skills
- Strong organizational skills and time management skills
- Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
- Ability to work independently and under general direction only
- Computer skills; MS Office, MS Project, Adobe Acrobat, and Agile
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. Employees must also interact with a computer and communicate with peers and co-workers.
A commitment to our employees' lives is at the core of our values. We recognize their contributions. They share in the success they help to create. We offer many benefits, resources, and competitive compensation plans to support you at every career and life stage. Learn more about our benefits here .
In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which allows you to earn significant incentive compensation for achieving or exceeding your goals. Learn more about total rewards here .
The provided base salary range is used nationally in the United States (except in Puerto Rico and specific CA locations). The rate offered complies with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. - 3 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
Senior Regulatory Affairs Specialist
- Philips
-
Plymouth, MN
FULL_TIME
- Job TitleSenior Regulatory Affairs SpecialistJob DescriptionLooking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our ...
- 3 Days Ago
Regulatory Affairs Specialist.
- Medtronic
-
Fridley, MN
FULL_TIME
- This job offer is not available in your country. Careers that Change Lives Medtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulator to treat chroni...
- 4 Days Ago
Advanced Regulatory Affairs Specialist
- BIO-TECHNE
-
Minneapolis, MN
OTHER
- Job Details Level: Experienced Job Location: Minneapolis MN - Minneapolis, MN Position Type: Full Time Education Level: Bachelor's Degree Salary Range: Undisclosed Travel Percentage: Negligible Job Sh...
- 6 Days Ago
Sr. Regulatory Affairs Specialist
- Oxenham Group
-
Paul, MN
FULL_TIME
- JOB SUMMARY The Regulatory Affairs Associate is required to work on a wide variety of regulatory tasks in maintenance of technical documentation, CE marking new devices and maintaining technical files...
- 7 Days Ago
Regulatory Affairs Specialist jobs at Popular Companies
Regulatory Affairs Specialist
- Net2Source Inc.
-
Palo Alto, CA
- Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
- 6/12/2024 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...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Experis
-
Maplewood, MN
- Our client, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will lead/ coordinate...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Alphatec Spine
-
Carlsbad, CA
- Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
- 6/11/2024 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...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Astrix
-
Fort Worth, TX
- Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Highridge Medical
-
Westminster, CO
- Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
- 6/9/2024 12:00:00 AM
Regulatory Affairs Specialist
- CM Medical Recruitment
-
- CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
- 6/8/2024 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
$78,101 to $104,664
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