Job Market Guide: Regulatory Affairs Specialist jobs - Nationwide

Competition
Low
0.068812
Based on job seekers per open jobs
Desired Skills
Years of Experience
Years of Experience distribution graph for Regulatory Affairs Specialists in Nationwide. Regulatory Affairs Specialists in Nationwide have between ${} and ${} years of experience, averaging $${} years of experience.

77 Regulatory Affairs Specialist jobs - Nationwide

Gaithersburg, MD
The Regulatory Affairs Senior Specialist will be responsible for the management and preparation of regulatory document packages to FDA for our investigational biodefense products, focusing on manufacturing, nonclinical, and clinical development
industry
Biotech/Pharma
experience
5 - 7 years

Mahwah, NJ
Assisting in the establishment and maintenance of regulatory information systems both electronically and hard copy.
industry
Medical Devices & Diagnostics
experience
Less than 5 years

Virtual / Travel
Prepare submissions(i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products.
industry
Medical Devices & Diagnostics
experience
5 - 7 years

Franklin Lakes, NJ
This position will be responsible for all aspects of regulatory affairs including development and execution of global regulatory strategies and submissions for medical devices and drug/device combination products. The incumbent will perform essential duties and responsibilities with some supervision while providing guidance to more junior regulatory associates.
industry
Financial Services
experience
Less than 5 years

Virtual / Travel
Support the preparation of documentation and materials required for meetings with Regulatory Authorities for assigned brand products.
industry
Manufacturing / Diversified
experience
5 - 7 years

Minneapolis, MN
Compile, author, and submit robust Regulatory submissions/technical files, and internal Regulatory file documentation, to expedite new product clearance/approval, and sustain commercial availability for all products.
industry
Life Sciences & Research
experience
8 - 10 years

Franklin Lakes, NJ
This position will be responsible for all aspects of regulatory affairs including development and execution of global regulatory strategies and submissions for medical devices and drug/device combination products. The incumbent will perform essential duties and responsibilities with some supervision while providing guidance to more junior regulatory associates.
industry
Financial Services
experience
Less than 5 years

Baltimore, MD
Coordinates timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale and Certificates of Exportability. Interfaces with applicable regulatory agencies and international consulates.
industry
Financial Services
experience
Less than 5 years

$50K - $80K - San Jose, CA
Provides metrics for regulatory management reporting and helps to identify areas for further monitoring for global product development system (GPDS) improvements.
industry
Medical Devices & Diagnostics
experience
Less than 5 years

Chicago, IL
Assists with the preparation and submission of documentation to regulatory agencies and other external bodies required to respond to regulatory inquiries, substantiate and approve claims and to gain approval of new ingredients.
industry
Food & Beverage
experience
5 - 7 years

San Diego, CA
Participate in cross-functional teams by working closely with product development engineering, marketing, clinical, and quality functions.
industry
Business Services
experience
5 - 7 years

Falls Church, VA
Coordinate and facilitate the meetings by providing panel members all necessary materials before the meeting, arranging and attending all meetings, and preparing a summary of the meeting proceedings.
industry
Healthcare IT
experience
5 - 7 years

Santa Clara, CA
Review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues. Author regulatory plan associated with the products.
industry
IT Consulting/Services
experience
5 - 7 years

Saint Joseph, MO
Provide technical and strategic regulatory information to BIV operative units in response to regulatory authority questions. May communicate with regulatory agencies as directed by line management.
industry
Biotech/Pharma
experience
5 - 7 years

Framingham, MA
Assist in the process for the development and release of labeling materials (Instructions for Use and patient materials) intended for users of HeartWare products. Assist in coordinating and executing all activities necessary.
industry
Medical Devices & Diagnostics
experience
8 - 10 years

Rensselaer, NY
Interact with other departments on site or at different locations, with customers and with suppliers for the preparation of regulatory submissions and responses to regulatory agencies questions.
industry
Information Services
experience
8 - 10 years

Saint Joseph, MO
Provide general regulatory input to local or international product (development) teams and other BIV departments as appropriate.
industry
Biotech/Pharma
experience
5 - 7 years

PLYMOUTH, MN
Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects.
industry
Medical Equipment
experience
11 - 15 years

Durham, NC
Manages planning and preparation of regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports. Ensures regulatory submissions are prepared and processed in a proactive expeditious and timely manner.
industry
Financial Services
experience
5 - 7 years

Irvine, CA
Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
industry
Business Services
experience
5 - 7 years

Santa Clara, CA
Participate in new product design and development project teams as regulatory affairs representative; ensure all regulatory requirements are met throughout the development process as per FDA QSR, ISO 13485, China FDA, Japan PMDA and Rest of the world regulations.
industry
Life Sciences & Research
experience
5 - 7 years

Bridgewater, NJ
Work with the Pharmaceutical Regulatory Affairs Senior Manager or other staff to make certain product documentation and support meets regulatory requirements; serve as designee as needed.
industry
Manufacturing / Diversified
experience
5 - 7 years

Saint Joseph, MO
Provide technical and strategic regulatory information to BIV operative units in response to regulatory authority questions. May communicate with regulatory agencies as directed by line management.
industry
Biotech/Pharma
experience
5 - 7 years

Franklin Lakes, NJ
Analyze and interpret current or proposed domestic and international regulations for impact to BD products and processes to help ensure continuous compliance.
industry
Financial Services
experience
5 - 7 years