Regulatory Affairs Associate: Medical Devices & FDA
Katalyst CRO
Katalyst CRO in Phoenix, AZ seeks an Associate Regulatory Affairs Manager to support regulatory documents for medical device and IVD products. You will help manage regulatory projects, align with FDA, ISO 13485, and global requirements, and work with cross-functional teams to support product approvals and lifecycle compliance. Responsibilities include preparing and submitting regulatory documentation, tracking timelines, and contributing to audits and regulatory communications. #J-18808-Ljbffr Katalyst CRO
$73.76k - $91.2k
Position Overview This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare AmericasCorporation. This position... ...to all applicable U.S. Food and DrugAdministration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485...Medical deviceRemote jobLocal areaFlexible hours- ...pharmaceutical, biotech, and medical device industries with our proven scientific... ...to complex trial data and regulatory submission challenges. With a... ...’ experience in Regulatory Affairs, Regulatory Operations,... ...Familiarity with 21 CFR Part 11, FDA, and GCP requirements....Medical deviceRemote jobLocal area
$74.1k - $148.3k
...Compliance Specialist provides guidance to cross-functional teams on medical device quality system compliance, with a focus on quality system... .... They assist with monitor compliance with changing European regulatory requirements and act as a subject matter expert on EU market...Medical deviceTemporary workFlexible hours- Responsibilities The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products. This role will assist in managing... ..., ensuring compliance with FDA, ISO 13485, and other global regulatory...Medical deviceWork at office
- ...validate, optimize, and maintain manufacturing processes for medical devices and components. The role emphasizes hands-on process validation... ..., and ongoing troubleshooting to drive yield, cycle time, and process stability in FDA-regulated #J-18808-Ljbffr Intellectt INCMedical device
- Canon Medical Systems USA, Inc. is seeking a Counsel to advise on general commercial, legal, and compliance matters for CMSU. You will draft... ...marketing collateral complies with Truth in Advertising and FDA requirements. You will handle litigation with outside counsel, develop...Medical device
- ...our team, focusing on facility validation, environmental monitoring and calibration for biopharma and medical device industries. This role requires strong regulatory knowledge, the ability to develop and execute sales strategies, and travel up to 40% of the time to meet...Medical device
$124k - $174k
...driving market penetration and revenue goals. The ideal candidate has 5+ years of sales experience, preferably in the aesthetics or medical device industries, with proven leadership and technical proficiency. This remote position requires significant travel. Salary ranges...Medical deviceRemote work- ...Phoenix, AZ Our client, a leading global company specializing in custom solutions for the medical device and pharmaceutical industries, is seeking an Accounts Payable Associate for its Phoenix, AZ location. The company designs and manufactures custom components using...Medical deviceWeekly payFull time
- ...sell Rohrer Aesthetics’ advanced capital equipment solutions to medical professionals, including dermatologists, plastic surgeons, and... ...in aesthetic capital equipment sales, preferably in the medical device or aesthetics industry. Strong sales aptitude with excellent...Medical deviceBase plus commissionRemote work
- ...automation maintenance. Production-output and OEE analysis. Knowledge of quality systems, FDA Quality System Regulation, cGMP, and relevant ISO standards. Medical device or pharmaceutical industry experience is preferred. Education Requirements: Four-year...Medical deviceRelocationShift work
$38 - $44 per hour
...aerospace & defense, automotive, energy, hi-tech, healthcare, medical devices, rail and semiconductor industries. We are looking... .... ~ Experience with FAI for electronic assemblies and associated components ~ ASQ or CQE certifications not required, but...Medical device$173k
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives...Medical deviceLocal areaImmediate startShift workNight shift- ...and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only...Medical deviceFull time
$145k - $150k
...Region: United States Territory Sales Manager-Laryngectomy | Atos Medical-US | Field position- candidate must maintain residency within... ...clinical excellence, patient support, and high-quality medical devices that help people breathe, speak, and live more comfortably. We...Medical deviceSummer workImmediate startWorldwideFlexible hoursNight shift- ...repairs, calibrates, and upgrades advanced medical equipment used in hospitals,... ...service careers into the growing medical device industry. Key Responsibilities... ...High School Diploma or GED required ~ Associate degree, trade school, or military technical...Medical deviceApprenticeshipInternship
- ...support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint... ..., and regulatory guidelines (ICH, FDA, EMA). Excellent scientific writing skills...Medical deviceRemote jobLocal area
- ...industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast... ...Education Requirements At least 8 years of Pharmaceutical, Medical Device or Healthcare Industry sales experience Ability to work...Medical deviceLive inWork at officeLocal area
- ...technologies, including CAD/CAM, 3D printing, and automated fabrication techniques. Ensure compliance with FDA, ISO, and other relevant regulatory standards for medical devices. Maintain strong vendor and supplier relationships to ensure the availability of high-quality...Medical device
- ...surgical robotics? Interested in working in the fast-paced, medical device industry in a new and exciting field of robotic micro-surgery... ...dedication to excellence to join us. MMI is seeking a Clinical Sales Associate to join our rapidly growing, talented team. This role will be...Medical deviceFlexible hours
$85k - $95k
...Nanosonics is a company that specializes in the development of innovative solutions for the automated reprocessing of reusable medical devices. Today, Nanosonics has a global presence with offices across Australia, Canada, the United States of America, Europe, the...Medical deviceFull timeLocal areaRemote work- ...Thoracent, a Maverix Company, is seeking a Territory Manager to join its team in Phoenix, AZ. This role offers a unique entry into medical device sales with hands-on experience in the operating room and exposure to cutting-edge procedures. Ideal candidates have a Bachelor'...Medical device
$69.5k - $110.9k
...Sterility Assurance and compliance to ANSI/AAMI/ISO, FDA Quality System Regulation, ISO13485 related to medical device sterilization, microbiology and related product... ...ANSI, AAMI, ISO, USP, FDA, EPA, and European regulatory standards and incorporate applicable changes...Medical deviceFull timeTemporary workFlexible hours- ...MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and...Medical deviceLocal area
$124k - $174k
...Education: Bachelor's degree Experience: 5+ years of contemporary sales industry experience. A background in the aesthetics, medical device, or dental industries is highly preferred. Leadership: Proven track record of hiring, coaching, and mentoring field-based...Medical deviceHourly payLocal areaRemote workRelocation- ...COMMITTED TO IMPROVING PATIENT CARE It takes a team of talented people to become one of the world's leading providers of innovative medical devices. AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated...Medical deviceContract workWork at office
- ...Lifesciences' values to build trusting, lasting relationships with medical professionals and industry partners. Your insight and... ...cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help...Medical deviceWork experience placement
$70k - $78k
...to solve the most critical and large-scale challenges across the aerospace & defense, automotive, energy, hi-tech, healthcare, medical devices, rail and semiconductor industries. Job Requirements Who We Are: Quest Global delivers world-class end-to-end engineering solutions...Medical deviceTemporary workWork experience placement- ...future of sterilization for the pharmaceutical, biotechnology, medical device, and life sciences industries. As the pioneer and market... ...pharmaceutical and/or medical device R&D, manufacturing, and regulatory processes and environments. Existing relationships within...Medical deviceContract workRemote work
- ...Location: Phoenix, AZResponsibilitiesSchedule and arrange appointments with doctors, respiratory therapists, case workers, and hospital medical teams, which may include pre-arranged appointments or regular "cold" calling.Conduct presentations to doctors, practice staff, and...Medical deviceNight shift
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