Regulatory Affairs Specialist jobs in Michigan
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 II
- myGwork - LGBTQ+ Business Community
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Maple, MI
FULL_TIME
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This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ business community.
Recruiter: Spencer Gregory Hale
Regulatory Affairs Specialist II
About The Role
At Boston Scientific, our products and technologies are used to treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Peripheral Interventions (PI) we design, develop, and produce technologies for diagnosing and treating peripheral artery and venous disease. We are able to provide a number of solutions to patients that include: Drug-Eluting Stents, Bare-Metal Stents, Catheters, Balloons, Guide Wires, Atherectomy, Thrombectomy and Intravascular Ultrasound. We have a robust product line and pipeline, and we will continue to make an investment in Peripheral Interventional treatments.
The Specialist II is responsible for Regulatory Affairs support of global regulatory submissions for the BSC product development process, integration of acquired products, and ongoing regulatory compliance.
Your Responsibilities Will Include- Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
- Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification, and follow-up of submissions under review.
- Develops and implements regulatory strategies for new and modified products.
- Acts as a core member on sustaining manufacturing and/or product development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
- Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
- Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes.
- Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
- Develops and implements departmental and divisional policies and procedures.
- Supports highly technical or major business segment product lines, special projects or strategic initiatives.
- Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.
- Minimum of a bachelor’s degree, preferably in a scientific or technical discipline. Professional certification(s) preferred
- Minimum of 3 years related experience, medical industry experience preferred; some regulatory affairs experience required
- Thorough understanding of FDA, European and international regulations
- Strong working knowledge of medical devices, procedures and terminology
- Working knowledge of product development process and design control
- Submission and presentation related computer skills, including experience with software applications such as Microsoft Word, Excel, PowerPoint and Adobe Acrobat
- Ability to effectively manage multiple projects
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. - 8 Days Ago
Regulatory Affairs Specialist
- Chromatech Inc. & B.V.
-
Canton, MI
FULL_TIME
- At Chromatech, we create color solutions in a wide variety of markets around the globe. You can become part of our Chromatech team by joining as a Regulatory Affairs Specialist. The right candidate wi...
- 9 Days Ago
Regulatory Affairs Specialist
- 1493 SIA MSD Latvija
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Riga, MI
FULL_TIME
- Job Description Do you want to help our Company become a highly relevant company in Latvia – while opening the doors to exciting, international career opportunities for yourself? Do you dream of a job...
- 13 Days Ago
Quality Assurance Regulatory Affairs Specialist
- Dexian
-
Kalamazoo, MI
CONTRACTOR
- Job Title: Project Associate, Quality Assurance Regulatory Affairs Specialist Duration: 12 Months contract with possible extension Location: Portage MI 49002Pay range: US$31 – US$41/hr.Description:Pla...
- 5 Days Ago
Senior Manager, Regulatory Affairs
- EV.Careers
-
Troy, MI
FULL_TIME
- Job Number: 61508Group: Magna CorporateDivision: Magna Services of America (Troy Office)Job Type: Permanent/RegularLocation: TROYGroup DescriptionAt Magna, we create technology that disrupts the indus...
- 7 Days Ago
Regulatory Affairs Engineer
- Talent Acquisition Team
-
Caledonia, MI
FULL_TIME
- ESSENTIAL DUTIES AND RESPONSIBILITIES: Supports the review of updated technical publications and standards to ensure continued compliance Supports the Customer Complaint process and performs MDR and v...
- 9 Days Ago
Regulatory Affairs Specialist jobs at Popular Companies
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
- 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
Regulatory Affairs Specialist
- Baylor College of Medicine
-
Texas City, TX
- Division: Office of Research Work Arrangement: Onsite only Location: Texas Medical Center, Houston, TX Salary Range: $54...
- 6/8/2024 12:00:00 AM
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...
- 6/7/2024 12:00:00 AM
About Michigan
Michigan consists of two peninsulas that lie between 82°30' to about 90°30' west longitude, and are separated by the Straits of Mackinac. The 45th parallel north runs through the state—marked by highway signs and the Polar-Equator Trail—along a line including Mission Point Light near Traverse City, the towns of Gaylord and Alpena in the Lower Peninsula and Menominee in the Upper Peninsula. With the exception of two small areas that are drained by the Mississippi River by way of the Wisconsin River in the Upper Peninsula and by way of the Kankakee-Illinois River in the Lower Peninsula, Michigan...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$75,353 to $100,981
Most Popular Cities in Michigan 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