Our science-driven medical device client is redefining expectations and advancing the field through cutting-edge solutions and therefore hiring a Director of Regulatory Affairs. The RA Director reports to the SVP of Clinical and Regulatory Affairs and will support the strategic direction, as well as lead the day-to-day execution of global regulatory activities. This role will be responsible for preparing high-quality regulatory submissions, supporting interactions with the FDA and other international regulatory bodies, and ensuring compliance

Our science-driven client is redefining expectations and advancing the field through cutting-edge solutions. The RA team is adding a Sr/Principal Regulatory Affairs Specialist to the team. The RA Specialist will report to the Director of RA and will lead and execute regulatory submission and approval activities for the company’s medical device products, with a primary focus on U.S. FDA submissions. This role will also provide support for international regulatory submissions outside North America. The Specialist will coordinate

 Our mid-sized medical device client is adding a Senior Quality Engineer to the team. The Sr. QE will support injection molding department and support operations and project teams by providing statistical and technical support through direct testing of products and processes to ensure that we consistently meet our customers' requirements. The role involves identifying opportunities for improvement in systems and products, leading quality assurance efforts, mentoring team engineers, focusing on Corrective and Preventive Action (CAPA) processes, and continuous improvement

Our mid-sized medical device client is adding a Post-Market Surveillance Manager to the team. The PMS Manager will be part of the clinical team and will lead post-market activities for medical devices, ensuring compliance with global regulations. As a subject matter expert, the Post Market Surveillance Manager will own and oversee clinical evaluation and surveillance processes, manage documentation (CEP, PMS/PMCF Plans, SSCP, PSUR, CER), provide leadership and development to the team and collaborate cross-functionally to maintain

Our mid-sized medical device client is adding a Senior Clinical Evidence Project Manager. The Project Manager will be responsible for the strategic management and oversight of all aspects of the Clinical Trial Team activities for assigned projects in accordance with the relevant standards as well as companies standard operating procedures. The Senior Clinical Evidence Project Manager, in collaboration with Clinical Program Managers and senior leadership, is accountable for achieving successful delivery of Clinical Team activities at the project level

Our mid-sized client is adding a passionate and high-energy Director of Business Development to expand their national footprint. If you're a proven closer with a strategic mindset, experience in Urology, and a strong grasp of partnership contracts — we want to talk to you. Our client provides state-of-the-art mobile healthcare services focused on advanced urology technologies — including shockwave lithotripsy (ESWL), laser lithotripsy (URS), and MR fusion biopsy. Their model is innovative, cost-effective, and deeply

 Our start-up medical device client is adding a Design Assurance Manager to the team. The DA Manager works cross-functionally and is responsible for providing Design Assurance representation on teams, facilitating design verification and validation for transfer to manufacturing, and implementing process/product improvements. The manager also supports quality management system process development and execution for applicable processes. The role has shared responsibility for product safety and quality in all stages of product and process development, and ensuring compliance with

Our mid-size cardiovascular client is adding a Senior R&D/Product Development Engineer to the team. The Engineer will lead product development activities from concept to commercialization. Your role with the company: Lead conceptualization, design and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements Acts as leader and/or primary technical contributor for cross-functional development team(s) that manage projects from concept through commercialization. Accurately and efficiently translates user

Our mid-size cardiovascular client is adding a Principal R&D/Product Development Engineer to the team. The Engineer will lead product development activities from concept to commercialization. Your role with the company: Lead conceptualization, design, and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements Acts as leader and/or primary technical contributor for cross-functional development team(s) that manage projects from concept through commercialization. Accurately and efficiently translates user

Our mid-sized medical device client is building a Program Management department. The Manufacturing Program Manager will oversee New Product Introductions, Capacity initiatives, and Transfer Programs. This role will work closely with plant leadership, quality, and the R&D group to create and establish a framework for oversight and management of NPI, Capacity Initiatives, and Transfer programs at manufacturing sites. This role works with internal and external customers, and technical resources are available to ensure effective execution of programs

Our mid-sized medical device client is adding a Sustaining Quality Engineer to support operations and project teams by providing statistical and technical support through direct testing of products and processes to ensure consistent customer requirement fulfillment.   Your role with the company: Focus on existing product line maintenance and continuous improvement. Implement and maintain Statistical Process Control (SPC) to enhance in-process controls. Support manufacturing operations to ensure consistent product quality. Conduct periodic reviews of established processes and update control

Our clinical-stage medical device company is adding a Clinical Trial Assistant to the team. This position represents an exciting opportunity to make an impact in early stages of clinical development for an innovative technology. As a member of the field team, the Clinical Trial Assistant is a professional who provides administrative support to clinical trials. Their primary role is to assist clinical research professionals, such as clinical research coordinators, study managers, and investigators, with the daily tasks involved in

Our mid-sized medical device client is adding a Production Supervisor II to the team. The Production Supervisor will be a key leader in driving operational success, overseeing all aspects of daily operations, from assembly to fabrication, while ensuring strict adherence to policies and procedures. In this role, you will be responsible for developing and empowering both people and processes, with a focus on enhancing safety, quality, productivity, and on-time delivery. This position requires a strategic mindset combined with

Our start-up, clinical-stage medical device client, is adding a Clinical Data Manager to the team. The Clinical Data Manager will support operational activities related to the organization's sponsored clinical research programs. Primary responsibilities are management of all aspects of clinical database design, development, and validation, including but not limited to case report form and report development, and query management. The Clinical Data Manager will establish, standardize, and maintain all policies and procedures necessary for the proper handling

Our start-up, clinical-stage medical device client, is adding a Clinical Research Associate to the team. The CRA will support operational activities related to the organization's sponsored clinical research programs. Primary responsibilities will be the start-up and management of assigned clinical sites and task and projects related to the preparation and administration of US and OUS clinical trials, including (but not limited to) the development of study materials, site training materials, clinical quality system documents, device accountability

Our clinical-stage startup medical device company is planning to execute two clinical studies to support a panel-track PMA device treatment for uncontrolled hypertension.  The Sr. Clinical Study Manager will be responsible for executing these two randomized, double-blinded studies in collaboration with the Chief Clinical Officer. The Sr. CSM will collaborate with CROs to support the PMA approval of the Class III device and will be broadly accountable for the execution of the clinical study. Your role with

Our small start-up client is adding a Regulatory Assurance Manager to the team. The RA Manager will work cross-functionally and be responsible for providing regulatory assurance representation on engineering, operations, and clinical teams. The manager will also provide input for process/product improvements. Your role with the company: ·        This position takes ownership of the Quality Management System (QMS) and is responsible for QMS process development and execution. ·        This position has shared responsibility for product safety and quality in all

Our mid-sized medical device client is adding a Sr. Clinical Research Associate to the team. The Sr. CRA is responsible for initiating and overseeing clinical centers to ensure the successful conduct of active clinical studies. The Sr. Clinical Research Associate will ensure that clinical centers perform the clinical study according to the study protocol and regulatory standards by qualifying, training, monitoring, and overseeing study conduct at multiple clinical centers. Your role with the company: Identify and assess the suitability

Our mid-sized contract manufacturing client is adding a Design Engineer to plan and develop robust designs per customer specifications. They work with some of the largest medical device manufacturers, defense contractors, and other large growing industrial companies. Their high-tech equipment is the backbone of precision manufacturing. CNC machining stations with 3-axis, 4-axis, and 5-axis capabilities enable them to perform multi-dimensional machining with unparalleled accuracy and efficiency.   Your role with the company: Work with customers