Fda Guidelines Jobs

This Principal Product Security Engineer role resides within the Technology Enterprise Strategy & Security team at Johnson & Johnson, focusing on securing medical device products. The position involves partnering with engineering groups to embed security by design throughout the product lifecycle, from pre-market development to post-market vulnerability management. Key responsibilities include creating and refining security processes, acting as a subject matter expert on cyber threats, and delivering critical documentation for regulatory compliance such as SOC2 and ISO 27001. The opportunity is appealing for its chance to directly impact patient safety while shaping industry standards in a Patient First culture. The role is based in Danvers, MA or Raritan, NJ, with a hybrid work arrangement requiring office presence three days per week.

This full-time Engineering Technician role supports injection molding operations within PMC SMART Solutions, a contract manufacturer producing life-saving medical devices and automotive components. The position involves executing mold trials, validating processes, and troubleshooting automation systems to ensure production efficiency. Key responsibilities include assisting with tooling setups, monitoring product quality, and collaborating with cross-functional engineering teams to drive continuous improvement initiatives. The role appeals to candidates seeking hands-on technical work in a regulated, high-impact environment where their contributions directly support critical healthcare and safety products. The position offers a collaborative culture focused on operational excellence and offers opportunities for professional growth within a certified, award-winning organization.

The Training Specialist role within the Quality and Compliance department supports the SOFIE network by developing and facilitating educational programs for manufacturing and operational staff. Key responsibilities include assessing training needs, creating individualized and group curricula, delivering face-to-face and virtual workshops, and ensuring compliance with cGMP regulations through collaboration with Quality Assurance and Sterility Assurance teams. The position requires domestic travel to various facilities to conduct hands-on training and manage onboarding processes. This opportunity appeals to candidates seeking a dynamic environment where they can drive organizational growth, implement innovative learning strategies, and contribute to high-quality pharmaceutical production standards.

This full-time Blood Bank Medical Director role within the Department of Pathology and Laboratory Medicine at Tufts Medical Center provides medical leadership for transfusion services, including the blood bank, apheresis unit, and stem cell laboratory. Key responsibilities involve overseeing blood product utilization, ensuring regulatory compliance, providing clinical consultations for complex patient cases, and supporting research initiatives. The position offers an academic appointment at Tufts University School of Medicine with opportunities to teach residents and medical students. The role is appealing due to its integration with a high-volume Level 1 trauma center, robust transplant programs, and a collaborative environment that values advancing knowledge through clinical and translational research. The position is based in downtown Boston.

This Principal Mechanical Engineer role serves as a technical lead within TransMedics' sustaining engineering team, driving innovation across the company's on-market product portfolio. Key responsibilities include leading end-to-end mechanical design development, conducting advanced structural and thermal analyses, and chairing program-level design reviews. The position also involves defining test methodologies, managing engineering change orders, and collaborating with manufacturing partners to ensure design for manufacturability. The role appeals to candidates seeking to impact patient lives by expanding access to viable donor organs in a mission-driven environment. While the position is based in the Boston area with potential relocation to Somerville by 2028, it offers opportunities for professional growth, cross-functional collaboration, and the chance to shape engineering standards in a high-impact medical technology setting.

This full-time onsite role at a Fortune 500 company involves supporting product development engineering within a regulated manufacturing environment. The position focuses on generating and executing formal test protocols, operating laboratory equipment, and maintaining precise technical documentation. Key responsibilities include tracking development builds, assisting with root cause investigations, and ensuring compliance with FDA and ISO standards. The role offers potential for permanent employment based on performance and provides opportunities for career growth within a collaborative team. Candidates will work in a lab and office setting in Salt Lake City, Utah, contributing to high-quality medical device development.

This senior leadership role at Neurocrine Biosciences provides strategic direction for clinical database programming across the company's neuroscience drug development portfolio. The position involves defining industry standards, overseeing database quality and regulatory compliance, and mentoring team members while managing complex technical projects. Key responsibilities include leading database builds and validation, evaluating new technologies, and ensuring inspection readiness for global submissions. The role appeals to experts seeking to drive innovation in a mission-driven culture focused on relieving patient suffering. It offers the opportunity to influence cross-functional decisions and shape long-term data strategies within a collaborative environment.

This full-time Warehouse Associate role at Kenco Logistics involves picking, packing, and preparing orders for shipment within a dynamic third-party logistics environment. Key responsibilities include measuring and weighing products, operating equipment such as forklifts, affixing shipping labels in compliance with regulations, and conducting quality inspections to ensure accuracy. The position offers a supportive culture that prioritizes employee growth, safety, and continuous improvement, allowing individuals to make a tangible impact in the supply chain industry. The role is based on-site with no travel required and provides opportunities for career development within a company that values integrity and innovation.

The Senior Director, Global Product Strategy & Product Management role serves as a senior leader within Accuray's Clinical Innovation and Education department, responsible for defining the multi-year strategy and direction of the company's cancer treatment portfolio. Key duties include developing long-term product roadmaps, overseeing the full product lifecycle from concept to launch, and integrating customer feedback with market intelligence to drive innovation. This position requires close collaboration with R&D, commercial teams, and executive leadership to ensure products meet clinical needs and business goals. The role is appealing for its opportunity to make a direct impact on cancer patient outcomes while leading a global team in a culture that values clinical curiosity, operational excellence, and patient-first innovation.

This full-time Bio Manufacturing Operator role is based onsite at Elanco's Elwood, Kansas facility, focusing on the production of monoclonal antibody drugs for animal health. The position operates on a 12-hour night shift schedule and involves executing core manufacturing processes such as media preparation, cell culture, and fill/finish while maintaining strict cGMP compliance. Key responsibilities include performing aseptic manipulations, documenting batch records, and supporting equipment maintenance within a sterile environment. The role appeals to candidates seeking to contribute to cutting-edge biologic research in a diverse and inclusive culture that values innovation. Opportunities for career growth are highlighted through a comprehensive benefits package and a collaborative team environment dedicated to improving animal lives.

The Program Manager II role leads cross-functional teams within Forj Medical to deliver complex medical device projects on time and within budget. Key responsibilities include managing customer expectations, negotiating contract changes, and coordinating schedules, budgets, and scope across engineering, manufacturing, and supply chain departments. The position requires guiding multiple medium-scale programs while ensuring compliance with FDA and ISO regulations. This opportunity appeals to professionals seeking a dynamic environment where they can drive process improvements and add value to diverse customer products. The role operates in a matrixed organization with a focus on collaboration and independent leadership.

This full-time onsite role within the Food Safety and Quality Assurance Department supports a wholesale food and beverage company in College Point, NY. The position involves managing supplier requests and private label approval processes, tracking vendor deductions alongside Accounts Payable, and procuring materials for laboratory testing. Key duties include representing the team during internal product evaluations and collaborating with compliance staff to update specifications and standard operating procedures. The role appeals to candidates passionate about food safety who seek to join an expanding team with opportunities for long-term growth. Strong organizational skills and the ability to manage multiple projects simultaneously are essential for success in this collaborative, cross-departmental environment.

This full-time on-site role supports clinical trials as a Research Pharmacy Technician within a collaborative healthcare environment. The position focuses on managing investigational products by receiving, storing, and dispensing medications while maintaining strict compliance with FDA regulations and study protocols. Key responsibilities include performing precise aseptic preparations, maintaining real-time accountability logs, and managing data entry in clinical trial systems. The role appeals to detail-oriented professionals who value precision and teamwork, offering opportunities for professional development and a supportive culture dedicated to improving healthcare quality. The schedule is Monday through Friday with a focus on regulatory adherence and operational efficiency.

This full-time Lead Clinical Laboratory Scientist role operates within a 25-bed critical access hospital in a scenic coastal region of California. The position serves as a technical consultant and supervisor for laboratory personnel, overseeing all testing operations, point-of-care coordination, and staff training. Key responsibilities include maintaining accreditation compliance with federal and state regulations, managing quality assurance programs, and ensuring equipment calibration and safety standards. The role appeals to professionals seeking a leadership position within a faith-based nonprofit organization that values community health and holistic care. The position offers the opportunity to work in a supportive environment surrounded by natural beauty, combining professional growth with a mission-driven culture.

The Lead Clinical Laboratory Scientist role serves as a technical consultant and supervisor for a 25-bed critical access hospital in Fort Bragg, California. The position involves overseeing all laboratory testing, managing point-of-care programs, and ensuring strict compliance with federal and state accreditation standards. Key responsibilities include developing quality control policies, coordinating equipment maintenance, and leading staff training and performance evaluations. This opportunity appeals to professionals seeking a leadership position within a faith-based nonprofit organization that prioritizes community health. The role offers the chance to work in a scenic coastal environment known for its natural beauty and small-town atmosphere while contributing to a mission-driven team.

This full-time Lead Clinical Laboratory Scientist role operates within a 25-bed critical access hospital in Fort Bragg, California, serving a coastal community. The position involves supervising laboratory personnel, managing all testing operations, and ensuring strict compliance with federal and state accreditation standards. Key responsibilities include developing quality control policies, overseeing equipment maintenance, coordinating point-of-care testing, and leading staff training programs. The role appeals to candidates seeking a leadership position in a faith-based nonprofit organization known for its compassionate mission and collaborative culture. The location offers a unique work-life balance with access to natural beauty, outdoor recreation, and a small-town atmosphere.

The Lead Clinical Laboratory Scientist role serves as a technical consultant and supervisor for a 25-bed critical access hospital in Mendocino County. Key responsibilities include overseeing all laboratory testing, managing quality control and regulatory compliance, and leading staff training and development. This position offers the opportunity to work within a faith-based nonprofit mission in a scenic coastal environment known for its natural beauty and outdoor activities. The role provides a collaborative atmosphere where professionals can drive operational excellence while enjoying a small-town community setting.

The Service Solutions Administrator role supports Drive Medical's global repair operations by managing critical data flows between SAP and Microsoft AX systems. Key responsibilities include entering service and repair data, resolving RMA exceptions, processing customer invoices for non-warranty repairs, and maintaining accurate inventory levels for repair components. The position serves as a vital liaison between the repair department and customer service to prioritize units and generate status reports. This opportunity appeals to candidates seeking a stable role within a leading medical device manufacturer, offering a collaborative environment focused on continuous improvement and safety compliance. The position requires strong organizational skills and proficiency with ERP systems to ensure efficient operations across the company's diverse product portfolio.

The Quality Program Manager role leads quality assurance initiatives within VisionGift's eye donation and tissue recovery programs. Key responsibilities include designing and maintaining quality management systems to ensure compliance with FDA, EBAA, and HIPAA regulations, conducting internal audits, and leading investigations into quality events to implement corrective actions. The position also involves analyzing operational data to drive continuous improvement and updating standard operating procedures. This opportunity is appealing for its mission-driven culture focused on restoring sight, offering a collaborative environment that values innovation and excellence. The role supports professional growth through engagement with regulatory standards and quality metrics, operating within a compassionate healthcare setting.

The Studio Manager role leads operations for a fast-growing boutique fitness franchise utilizing advanced EMS technology. The position involves overseeing daily studio activities, managing sales and training staff, and executing marketing initiatives to drive revenue and member engagement. Key responsibilities include hiring, performance evaluation, inventory management, and ensuring compliance with safety protocols. This opportunity appeals to candidates seeking a dynamic environment within a mission-driven company focused on fitness equality and personal growth. The role offers a full-time schedule with a supportive culture, professional development, and employee wellness benefits.

The Packaging Quality Supervisor role is a full-time position within the Quality department at a beverage facility in Rochester, NY. This leader oversees packaging quality functions, manages a team of analysts, and ensures compliance with FDA and TTB regulations. Key responsibilities include directing product safety testing, leading root cause investigations for quality issues, maintaining laboratory operations, and facilitating new product commercialization. The position offers a collaborative culture focused on continuous improvement and community involvement, supported by flexible scheduling, generous paid time off, and comprehensive benefits. While primarily based on-site, the role includes occasional travel to suppliers and customers for technical support and audits.

This senior management role within Pfizer's Vaccines portfolio focuses on leading the U.S. strategy and execution for the Prevnar 20 pediatric vaccine. The position involves developing and implementing high-impact healthcare provider tactics to differentiate the brand against competitors and drive market preference. Key responsibilities include managing digital engagement initiatives, optimizing marketing resources, and collaborating with global stakeholders to support the brand's AI and digital transformation goals. The role appeals to candidates seeking a mission-critical position in a leading pharmaceutical company, offering opportunities to influence major public health outcomes and work within a collaborative, matrixed environment. The position is hybrid, requiring onsite presence two to three days per week at either the New York or Pennsylvania headquarters, with occasional domestic and international travel.

This full-time Processing Tech I role within the Production Processing Department at Vitality Works supports the manufacturing of herbal and nutraceutical supplements. The position involves sanitizing equipment, measuring and blending ingredients, operating machinery, and monitoring kettle processes to ensure high-quality output. Key responsibilities include maintaining a clean and safe work environment, adhering to standard operating procedures, and documenting production records. The role appeals to candidates seeking a mission-driven environment focused on health and sustainability, offering a collaborative team culture and comprehensive benefits including health coverage, a 401(k) match, and on-site wellness facilities. The position is based on-site and requires the ability to perform physical tasks in a fast-paced manufacturing setting.

This midlevel Information Security Analyst role supports the 88th Medical Group at Wright Paterson Medical Center, protecting networks for over 2,500 users across seven buildings. The position involves implementing cyber security programs, enforcing Department of Defense compliance policies, and managing endpoint security applications. Key responsibilities include troubleshooting operational issues via tracking systems, conducting information assurance inspections, and overseeing vulnerability patching and firewall request management. The role offers the opportunity to work within a major military treatment facility that integrates civilian and government personnel, providing a stable environment with comprehensive health, retirement, and leave benefits. This position is fully on-site.

This full-time Radiology Technologist role supports the Orthopedics clinic at Avera Medical Group in Sioux Falls, operating on a four-day, 36-hour weekly schedule. The position involves performing high-quality diagnostic radiology procedures, managing patient care throughout examinations, and maintaining equipment and inventory. Key responsibilities include ensuring strict adherence to safety and quality assurance protocols, coordinating image sharing with external providers, and facilitating communication between the department and physicians. The role appeals to candidates seeking a compassionate, multidisciplinary team environment focused on advancing patient health. Benefits include immediate paid time off, retirement matching, and structured career development through mentorship and hands-on training.