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Our mid-sized medical device client is adding a Director of Regulatory Affairs to the team. The Director will have 7 direct reports with one being OUS. The RA team currently reports to the VP RA/CL/QA and because of growth, they are adding a Director. Bring your experience in the medical device industry with you to explore this fascinating company, be part of the integration, and play a role in these trail-blazing opportunities. Ready to make a difference by utilizing your talents? Join a team


Our mid-sized medical device client is building their regulatory department and have recently launched over 18 new products into the market with additional products this year! They have brought on new senior leadership and implementing a 3-year global quality and regulatory improvement program. This is a ground floor opportunity to write new submissions, remediation and new MDR work. The regulatory leadership team is creating a fun, possitive environment! The Sr. Principal RA Specialist will....


Our mid-sized medical device client is building their regulatory department and launching over 20 new products into the market! They have brought on new senior leadership and implementing a 3-year global quality and regulatory improvement program. This is a ground floor opportunity to write new submissions, remediation and new MDR work. The regulatory leadership team is creating a fun, possitive environment! The Sr/Principal Specialist will prepare and submit regulatory submissions to....


Our smaller medical device client is adding a Sr. Clinical Research Associate to the team. They are driven to improve and extend the life of patients suffering from neurological diseases by providing an innovative technology for patients with neurological diseases. The Sr. CRA will work with the Clinical Study Manager to satisfy applicable regulatory standards and internal requirements for worldwide clinical studies. Bridges the responsibilities of the Clinical Study Coordinator and the....


Prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to European notified body to support distribution and marketing objective set by divisional and corporate staff.Inform project teams of new and changing regulatory requirements.Update RA procedures as needed to ensure company is in compliance with new and changing regulatory requirements.Keep abreast of new and changing regulatory requirements.Review and approve....


Our early stage medical device manufacturing start-up client is adding a Systems Engineering Director/VP to the team. The hands-on manager will provide interdisciplinary research and product development leadership from inception through pilot production. He or she must be able to work effectively with all functional groups to define system-level requirements and resolve cross-functional issues. Your role with the company: Define, plan, and execute development programs to implement design....


Our mid-sized medical device client is building their regulatory department and launching over 20 new products into the market! They have brought on new senior leadership and implementing a 3-year global quality and regulatory improvement program. This is a ground floor opportunity to write new submissions, remediation and new MDR work. The regulatory leadership team is creating a fun, possitive environment! The RA Specialist will prepare and submit regulatory submissions to Regulatory....


Our mid-sized client is growing and adding a Sr. Clinical Project Manager to the team! Need to have written clinical protocol's independently and written a protocol from start to finish. This person will be reporting to the Sr. Clinical Manager. Your role with the company:Development of clinical study protocols and ensuring clinical compliance in the conduct of clinical studies. Reviews clinical data, provides direction on analysis of data, and develops clinical study reports with high....


Our start-up medical device client is developing a novel transcatheter device used to treat mitral regurgitation. This is a new position where the Principal Engineer will participate in the selection of an overall concept and development of a full product development cycle. In addition, this individual will assist the Director, Product Surveillance in developing infrastructure related tools as it relates to all companies programs. Your role with the company:Participate in the design and....


Our mid-sized client is adding a Vice President of Global Regulatory Affairs to their team! The VP Regulatory will have multi-site responsibility for developing and leading the regulatory and technical communication strategy to support the product lifecycle of companies products from product development through commercialization. Will provide regulatory insight (raising potential issues/concerns) on business matters, establish and maintain effective relationships with regulatory bodies such as


Our 15-person, start-up medical device client is developing a novel, minimally invasive technology for structural heart disease. The team is adding a Principal Design Assurance Engineer who will report to the Sr. Director of Quality. The Design Assurance Engineer will be responsible for new product development (conception to launch) and sustaining projects. Lead for the planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design....


Our mid-sized medical device client has a small office in the southwest suburbs and they are looking to add a Sr. Regulatory Operations Specialist to their team! This person will have the opportunity to work remote 2 days a week. They have doubled revenue in 36 months. This will be a great opportunity to learn new things and gain new experiences in a smaller, more nimble company This position will be responsible for analyzing and supporting/resolving functional business issues and needs, as....


Our mid-sized, private equity-backed global client is adding a Principal Clinical Affairs Specialist. The candidate will be working with life-saving medical device technology development and commercialization. The company has a rich history of innovation as well as a recognizable brand in their segments of the industry. This global business sells their products directly in addition to utilizing a wide array of distributors around the world. With a strong platform, new products under....


Our growing, mid-sized medical device client is adding a Sr. Quality Engineer to their team. The Sr. QE will be part of the Quality Assurance and Regulatory Affairs group and is responsible for developing, maintaining and improving the quality system in accordance with quality system requirements, domestic and international quality and regulatory standards for all applicable jurisdictions. The focus of this Sr. QE role will be focused on new product development, risk management and reliability


Our 12-person fully financed neuro start-up client is adding their first Regulatory Specialist to the team! The Sr/Principal Regulatory Specialist will manage and perform regulatory activities for obtaining product approval/clearance within the organization. This role will be primarily responsible for the preparing of U.S. and global (as applicable) regulatory submissions and will work closely with other core team members across the organization. Your role with the company: - Develop and....


Our mid-sized medical device client has a small office in the southwest suburbs and they are looking to add a Regulatory Specialists. This person will have the opportunity to work remote 2 days a week. They have doubled revenue in 36 months. This will be a great opportunity to learn new things and gain new experiences in a smaller, more nimble company.Manage regulatory submissions including registration strategy, timeline and submission coordination, development/review of documentation,....


Our 10-person, start-up medical device client is developing a novel, minimally invasive technology in the Twin Cities. This is a newly created position and will be the only Clinical Project Manager reporting to the Director of Clinical. Primary Responsibility: * Drafts clinical trial protocol, protocol amendments, and study reports, as directed. * Develops and executes research tracking databases and spreadsheets to provide relevant information for Clinical Studies management. * Manages....

- Minneapolis, MN

The Clinical Science Manager is responsible for the scientific review and publication of data related to the company’s products, technology, and strategy. This person will manage the company’s publication portfolio and external research proposals/grants and assist with scientific data analysis.Primary Organization Responsibilities Establish a publication/presentation strategy that meets the needs of external and internal stakeholders and manage the project timelines for generation of....


Our 12 person small R&D facility is adding a Sr/Principal Product Development Engineer to the team. The medical device company develops and manufactures minimally invasive, single-use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. The products they develop and manufacture are typically market disruptive and displace higher cost procedures. Your role with the company:Work collaboratively with other engineers and personnel from client companies assigned


Our client, a small clinical trial stage company is adding a Sr. Regulatory Affairs Specialist to their team. The Specialist will engage in planning and execution of global regulatory activities necessary to support implementation of clinical trials and subsequent commercial distribution of companies products. This position will provide regulatory functional representation and review of documentation related to clinical trials, labeling, design and specification, and manufacturing processes,....

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