Product registration is the activity that adapts the product to the legislation. It is the process done before marketing for the product to be evaluated and become fit for marketing.
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The Fountain Group. is a national staffing firm and we are currently seeking a. Regulatory Specialist. for a prominent clientof ours. This position is located in. Alameda, CA (onsite). Details. THIS POSITION IS 100% ONSITE. Pay for this position is 56.00 to 60.00 hourly depending on experience. This position is a one year contract with the possibility of extension or conversion to permanent. Required. 5 years of regulatory affairs experience. Med...
The Fountain Group is a national staffing firm and we are currently seeking a Regulatory Affairs Associate for a prominent client of ours. This position is located in Santa Clara, CA Details for the position are as follows. Job Description. Details. Pay for this position is 40.00 to 45.00 hourly depending on experience. This position is a contract with the possibility of extension or conversion to permanent. Description. Responsible for filing ne...
Duties. Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing / operations day to day activities for change control. Provides consultation / advice to regulatory specialist for change control and product development. Provides regulatory direction / interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Prepares U.S. regulatory subm...
Duties. Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing / operations day to day activities for change control. Provides consultation / advice to regulatory specialist for change control and product development. Provides regulatory direction / interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Prepares U.S. regulatory subm...
Consultant, Regulatory Specialist, Tissue Bank / Pharmaceutical. Summary. Our client, an Innovative Medical Device company, has engaged GForce Life Sciences to provide a Regulatory Specialist. This position will report to a Manager within the Regulatory department. This individual will play a crucial role in ensuring compliance with regulatory requirements governing tissue banking operations. They are responsible for submitting state licensing fi...
Job Title. Regulatory Affairs Specialist II. Location - 2901 Harbor Bay Parkway, Alameda, CA 94502. Duration – 12 Months. Pay rate - $59/hr. Years of Experience. At least 5 years. Location. On-Site (5-days a week). Experience Background (Any). Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance, SW Engineering, APAC regulatory submission, or APAC-related work under Quality Assurance/Engineering. Job Description (Expectation). Re...
Our client is seeking a skilled and dynamic Senior Regulatory Affairs Specialist for a temporary position. As a pivotal member of their team, you will play a crucial role in ensuring compliance with medical device regulations, particularly the EU Medical Device Regulation (MDR). The ideal candidate for the Senior Regulatory Affairs Specialist role will possess 3-5 years of experience in regulatory affairs, with a strong background in EU MDR, regu...
POSITION IS 1 YEAR FROM START DATE WITH POSSIBLE EXTENSIONS. On-Site. Top experience manager is looking for. Risk management. Product management. Product registrations. Impact assessment knowledge. Chinese or Japanese bilingual- optional. Occasional Night call- 4-5 PM, 5-6 PM or 6-7 PM. Team environment- 5 people currently. Very open and collaborative team. Experience Background. Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assuran...
SUMMARY. The. Regulatory Affairs Associate. will be responsible for overall product safety and regulatory compliance for products. Works closely with regulatory team members worldwide to ensure product compliance. RESPONSIBILITIES. Acts as a regulatory consultant to ensure all products comply with applicable regulations and market needs (e.g., TSCA, FDA, NSF). Respondto internal and external product regulatory inquiries, including, e.g., EPA, FDA...
8/1/23 Nadine - We just spoke with the hiring manager, and he updated the role with the below notes. Need to understand the process to commercialize and go to market with a new assay. Understands the purpose of a design control. Understand the process of going to a clinical trial and the documents needed. Understand the regulations and requirements around submitting a device to an agency in EU, UK, and rest of world. Knows what doing a submission...
Overview. Werfen. Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than...
Purpose: The Senior Regulatory Affairs Specialist will provide regulatory support for New Product, Sustaining Engineering, and/or Operations project teams by identifying the appropriate domestic and international regulatory requirements and developing a regulatory strategy for global product commercialization. They will ensure product registrations are completed in accordance with project schedules. They will assess the domestic and/or internatio...
