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Regulatory Affairs Associate Jobs

81 jobs

Minimum 3-5 years experience in Regulatory Affairs. Direct experience in filing necessary applications and government interactions pertaining to the regulation process for products requiring governmental approval. Experience with 510(k)s, PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Proven successful track record of authoring/submission/clearance or appr...
Regulatory Affairs Associate Director, Global Labeling Eastern Montgomery County, PA Experienced Regulatory Affairs Associate Director needed for longer term contract position. This position offers a great work environment and excellent compensation! Great opportunity to be part of a premiere pharmaceutical organization! Summary: The Regulatory Affairs Associate Director, Global Labeling, will...
Senior Regulatory Affairs Associate Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Regulatory Affairs Associate. The Senior Regulatory Affairs Associate supports a variety of activities in the Regulatory Affairs d...
JOB DESCRIPTION: To support the Regulatory Affairs team with the data review of ingredient and labeling information in Product Vision for a Portfolio-wide elimination of artificial flavors and colors. Confirm completeness data for ingredient specifications and Raw Material Dossiers. Assess and confirm data for labeling documents. Evaluate new ingredients vs current and determine impact to labels....
JOB DESCRIPTION: To support the Regulatory Affairs team with the data review of ingredient and labeling information in Product Vision for a Portfolio-wide elimination of artificial flavors and colors. Confirm completeness data for ingredient specifications and Raw Material Dossiers. Assess and confirm data for labeling documents. Evaluate new ingredients vs current and determine impact to labels....
Job Title: Regulatory Affairs Associate Location: Lake Forest, IL, 60045 Duration: 9 months (Contract) Responsibilities: · Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. · Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements and ...
PRIMARY FUNCTION: Provides regulatory affairs support by preparing labeling and supplements for FDA drug dossiers for new product presentations. May serve as a lead regulatory representative for some project teams. MAJOR DUTIES AND RESPONSIBILITIES: Provides regulatory advice and support to assigned products/teams. Identifies and communicates regulatory needs and strategies. Maintains awareness...
Job Description: Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of companies products. Responsibilities: • Track of status and progress of regulatory documentation • Review, edit and proofread regulatory documentation • ...
Job Description: Job Summary Responsible for assisting the team with regulatory filings as necessary to market products. This is an entry level position, providing training towards full competency in Regulatory Affairs. This position requires an understanding of medical device products and their use as well as an understanding of the regulatory admissions process. Principal Duties and Responsibil...
Overview The Regulatory Affairs Associate, PARC Operations is responsible for managing materials through Tevas Promotion and Advertising Review Committee (PARC) process. The PARC process supports the review/approval of all product advertising and promotional materials, as well as other related materials, (e.g., disease awareness campaigns, sales training materials, etc.) to assure adherence to es...
Overview Cures Start Here.At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the...
Overview: Bard Peripheral Vascular, located in Tempe, AZ where a tradition of vascular innovation spans decades of focusing on improving the quality of patients lives. From C. R. Bards first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices for p...
Bard Peripheral Vascular, located in Tempe, AZ – where a tradition of vascular innovation spans decades of focusing on improving the quality of patients’ lives. From C. R. Bard’s first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices for peripher...
Overview: Bard Peripheral Vascular, located in Tempe, AZ – where a tradition of vascular innovation spans decades of focusing on improving the quality of patients’ lives. From C. R. Bard’s first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices f...
Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This is an entry level position, providing training towards full competency in Regulatory Affairs (RA). This position requires an understanding of Zimmer Biomet products and their use as well as an understanding of the regulatory admissions process. May perform some or all of the following fun...
Job ID: 105299 3M is seeking a Regulatory Affairs Associate for the Critical and Chronic Care Solutions Division (C3SD) located in Maplewood, MN. Ready to be part of what’s next? Job Summary : The person hired for the position for the Regulatory Affairs Associate wilI lead medical device and combination product registration activities globally. Primary Responsibilities include but are not limi...
Regulatory Affairs Associate-KAV000360 Danaher Company Description Description Qualifications Danaher Corporation Overview Organization: KaVo Kerr Group - Dental Technologies Job Function: Regulatory Primary Location: North America-United States-NC-Charlotte : Schedule: Full-time : _cn_ Beckman Coulter Inc _rfc_ 551536...