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Regulatory Affairs Specialist Jobs

289 jobs

Current Opportunity: We currently have an opening for a SENIOR REGULATORY SPECIALIST to work out of our manufacturing facility in St. Louis, MO or Smyrna, TN. This opportunity is responsible for a0dvise and recommend policies to ensure compliance with Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Association (OSHA), Consumer Products Safe...
Title: Chemistry State Regulatory Affairs Specialist Type: Contract Time Period: February 2016 through August 2016 Description We are seeking a highly motivated individual for a period of 6 months to assist with regulatory submission of products. The successful candidate will be responsible for assisting the Regulatory Affairs Manager in filing necessary applications for state product registra...
CyberCoders Matching Great People with Great Companies Learn more about CyberCoders Sr. Regulatory Affairs Specialist Apply San Jose, CA Full-Time $90,000 - $120,000 Job Details If you are a Sr. Regulatory Affairs Specialist with experience, please read on! We are located in San Jose, CA and are a major player in the Medical Device Industry. We are currently looking to hire a very experie...
CyberCoders Matching Great People with Great Companies Learn more about CyberCoders Regulatory Affairs Specialist - EU Regulatory Requirements - SME Apply Princeton, NJ Full-Time $120,000 - $130,000 Job Details We have an outstanding career opportunity for a Regulatory Affairs Specialist or Regulatory Affairs Subject Matter Expert (SME) with EU regulatory experience to join a growing globa...
SUMMARY: Prepare FDA and international submissions for new products and product changes, including labeling, to ensure timely approval for market release in accordance with applicable regulations, standards, and guidance. Maintain regulatory affairs application files to support compliance with requirements and standards. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties m...
Collaborative is seeking a Regulatory Technical Writer for long term contract position with large pharmaceutical company located in North Chicago, IL Position Description: Regulatory Affairs (RA) requires a Technical Writer with professional regulatory experience (i.e., regulatory submissions, regulatory labeling, regulatory advertising and promotion) and policy, process, procedural (Quality Sys...
Leading IVD company in San Diego requires a Regulatory Affairs Specialist to prepare international submissions (CE, US, Australia & Canada) as well as Pre-Sub, 510(k), PMA & PMA supplement submissions. This is a 6 month contract position with potential to go full-time. Key Skills Include: - 2+ years' experience - Experience in both US & International Registrations - Knowledge of regulatory req...
Position Description The Senior Regulatory Affairs Specialist (NDT) is responsible for developing global regulatory strategy, preparing submissions and obtaining approval to introduce Medtronic Inc. products and therapies. Position Responsibilities • Provide regulatory support for new products/therapies and changes to existing products. Work with other RAS, engineers and technical experts to re...
Position Description: We currently are seeking a dynamic and innovative International Regulatory Affairs Specialist. This key position will be based in our corporate offices in Northridge, CA (So. CA). For more than 40 years, Pharmavite has been a trusted leader in the wellness industry, recognized for providing quality vitamins, minerals and supplements and all natural snacks under our Nature M...
Life-changers work here At CareFusion, we create innovative ways to help our customers improve patient care. We rely on bold and inspired employees who share our commitment to helping solve some of healthcare's most critical challenges. CareFusion is now part of Becton Dickinson, a global medical technology company focused on addressing many of the world's most pressing and evolving health needs...
REGULATORY AFFAIRS SPECIALIST REQUIREMENT #16-005199 RECRUITER: CINDI PISNOY JOB LOCATION: PLAINSBORO, NJ FEBRUARY 2, 2016 *** CANDIDATES MUST BE ABLE TO WORK ON OUR PAYROLL AS A W-2 *** Project Description: Provide proactive support and technical assistance during preparation and review of regulatory documents. Assist with technical preparation for FDA meetings, including review of draft ...
SR. REGULATORY AFFAIRS SPECIALIST (SRAS-VK) Provide leadership to dvlpmnt, new product intro & mfg teams for assessing mpact of dsgn inputs & outputs on regulatory filings & compliance. MS+3 yrs rltd exp. Send resumes to Intuitive Surgical Operations, Attn: Rebecca Counihan, 1020 Kifer Road, Sunnyvale, CA 94086. Must ref title & code. _cc_ xhj282_3718430x _cn_ Intuitive Surgical Operations _rfc_...
Position Description: We currently are seeking a dynamic and innovative Regulatory Affairs Specialist. This key position will be based in our corporate offices in Northridge, CA (So. CA). For more than 40 years, Pharmavite has been a trusted leader in the wellness industry, recognized for providing quality vitamins, minerals and supplements and all natural snacks under our Nature Made® and SOYJO...
Our client is currently seeking a Regulatory Affairs Specialist. BA/BS in Scientific discipline required. Engineering strongly preferred RAC certification desired Ensure compliance to all internal, US, EU and other international requirements and corporate policies and procedures for market approval of medical devices/combination products. Apply scientific principles to understanding safety and...
Requirements: Bachelor’s degree, or equivalent formal training and experience. Three (3) years minimum in a cGMP quality, regulatory, and / or chemical manufacturing environment, with previous experience writing and managing documentation prepared in support of drug applications with national and / or international regulatory agencies. Skills: Excellent written and spoken communication ability; p...
Senior Regulatory Affairs Specialist Validus Pharmaceuticals is currently seeking an experienced Senior Regulatory Affairs Specialist to join our team in Parsippany, NJ. About Us: Validus is focused on acquiring, reformulating, and marketing prescription products in specialty therapeutic areas. Our business is based on acquisition of established products that are FDA-approved and satisfy unmet ...
Regulatory Affairs Specialist Requirements: -BA/BS in Scientific discipline. Engineering strongly preferred (Will consider someone without a Bachelor's if they have strong RA DEVICE exp.) -Experience in 510(k), IDE, PMA (original/revision/supplements) preparation is a plus -Minimum 2 years’ experience in FDA regulated industry -Working knowledge of Medical Device Regulations (FDA required, in...
The details for this position are as follows: Job Title: Regulatory Affairs Specialist Job Code: RCI-SA-4497386 Job location:- Cambridge, MA 02142 Duration: 6 Months JOB DESCRIPTION: This individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual updates, NDA annual repor...
Regulatory Affairs Specialist Description: - Create, manipulate and analyze nutrition data, complete compliance reports, calculate child nutrition component contributions for products sold in school meal programs, provide support for health professional conferences, assist in the review of wellness communications, and provide general nutrition support for the department. - Interface with food a...
DescriptionQfix is a dynamic privately held, rapidly growing innovator, manufacturer and marketer of advanced composite products for patient positioning in medical imaging headquartered in beautiful rolling hill country just west of Philadelphia, with sales in over 60 markets across the globe. The Regulatory Affairs Specialist provides global support for Class I and Class II medical devices; is r...