Regulatory Affairs Lead — Medical Devices (510(k)/De Novo)
Katalyst CRO
A leading pharmaceutical manufacturing company is seeking a Regulatory Affairs Specialist III in Austin, TX. This mid-senior level role focuses on global product registrations and ensuring regulatory compliance in the medical device sector, particularly for respiratory devices. The ideal candidate will have over 5 years of regulatory experience and a strong understanding of ISO standards, FDA regulations, and CE marking. #J-18808-Ljbffr Katalyst CRO
$93.68k - $140.52k
Regulatory Affairs Specialist III - Katalyst CRO Location: Austin... ..., and sales of medical devices (including Class I and... ...medical device, and de novo devices). obtaining... ...requirements as applicable. 510(k) and/or De Novo... ...understands relevant impacts. leading corrective and...Medical deviceContract work- ...Innovation Company Pty Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for medical devices in Austin, Texas. This position demands... ...including medical, dental, and vision insurance, a 401(k) plan, and paid time off. #J-18808-Ljbffr KICO...Medical device
- ...responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe,... ...registrations and related regulatory affairs activities, including execution... ...Assess necessity for submitting a 510(k) application for proposed device...Medical deviceContract workWork at office
- Job Title Senior Regulatory Affairs Specialist Location Austin, TX Summary We are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory... ...changes and execute notifications, new 510(k)s, letters to file, technical file...Medical deviceFull timeLocal area
- Global medical device corporation is seeking a Professional Education Compliance Lead to be responsible for overseeing all compliance aspects... ...to U.S. and global regulatory requirements and internal policies... ..., Legal, Finance, Medical Affairs, and Education teams. This...Medical deviceWork experience placementWork at officeLocal area
- ...specializes in developing innovative medical devices aimed at addressing... ...here. Position Objective The Regulatory Affairs (RA) Specialist is... ...and submission activities (510(k), IDE, PMA, EU/CE Technical... ...willing to take initiative and lead regulatory projects. Preferred...Medical deviceWork at officeWorldwideFlexible hours2 days per week3 days per week
$71k - $119k
Neuralink is seeking a Regulatory Engineer to manage regulatory affairs and collaborate with R&D teams in Austin, Texas. The role involves preparing regulatory submissions and ensuring compliance with global standards. The ideal candidate holds a Bachelor’s Degree in Engineering...Medical device- On-X Life Technologies, Inc. seeks a Regulatory Affairs Specialist based in Austin, TX. This hybrid... ...developing regulatory strategies for medical devices, preparing submissions, and ensuring... ...comprehensive medical coverage, a 401(k) plan, and competitive PTO. #J-18808-...Medical device
- ..., and some experience in logistics or inventory management. This position offers 5 weeks of paid time off, comprehensive health coverage, and a 401(k) plan with company match. Other benefits include tuition reimbursement and employee discounts. #J-18808-Ljbffr ArtivionMedical device
- Artivion, Inc. in Austin is seeking a Regulatory Affairs Specialist to develop regulatory strategies... ...and ensure compliance for innovative medical devices, including the On-X Mechanical Heart... ...comprehensive medical insurance, 401(k) options, and tuition reimbursement,...Medical device
$129.3k - $258.7k
...technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 1... ...people in more than 160 countries.Descritivo de Cargo**Job Title****Group Manager - Strategy and Analytics...Medical deviceTemporary workWorldwideShift work- ...Territory Manager in Austin, Texas. This role is focused on managing commercial business and requires strong sales skills within the medical device industry. The ideal candidate will have at least five years of relevant experience, the ability to build customer relationships...Medical device
$99.3k - $198.7k
Abbott is seeking a Principal Analyst in Austin, TX to manage and develop medical device contracting templates, interface with various departments, and lead negotiations on contracts. The ideal candidate should have a Bachelor's Degree and at least 8 years of experience...Medical device$68k - $114k
A leading medical technology company in Austin seeks a Prototyping Lab Engineer & Manager to enhance lab operations and support innovative medical device development. The role focuses on designing lab spaces, managing inventory, and providing technical assistance for prototyping...Medical device$129.3k - $258.7k
...for the Division's products through strategic marketing plans, leading staff development, and serving as a subject matter expert in... ...'s degree and 8+ years of experience in the healthcare or medical devices sector. The position offers a competitive salary range of $12...Medical device- OriGen Biomedical in Austin, TX seeks a Cleanroom Line Lead to supervise assembly, testing, and packaging of medical devices. This role requires strong leadership skills, adherence to quality standards, and the ability to motivate a team in a cleanroom environment. Candidates...Medical device
- Renesas Electronics Corporation seeks a skilled System Architect in Austin, Texas, to lead the development of semiconductor-based systems for medical and healthcare applications. The ideal candidate will have a Master’s or Ph.D. in Engineering, 12+ years of relevant experience...Medical deviceFlexible hours
- ...minimum of two years of customer service experience, ideally in the Medical Device or Pharmaceutical sector, and proficiency in MS Office. This... .... Benefits include paid time off, medical/vision insurance, and a 401(k). Join us in making a difference! #J-18808-Ljbffr...Medical device
- ...C++ Dev Lead/Architect Location: Austin, TX (Onsite) Duration: 6+ Months Job Description: Ability to architect... ...also knowledge of design patterns, preferably in Healthcare & medical software device domain. Strong experience in Linux / C++ Experience in...Medical device
- ...construction projects including chiller plants and chemical systems, leading site operations and ensuring adherence to safety and quality... ...and piping system knowledge. Excellent benefits including medical plans, 401(k) matching and employee discounts will be offered. #J-18808-...
$68k - $114k
Latent AI in Austin, Texas, is looking for a Prototyping Lab Engineer & Manager to enhance lab operations supporting groundbreaking medical device innovations. Responsibilities include managing lab design, providing hands-on support in prototyping, and ensuring compliance...Medical deviceFlexible hours- STV Construction Incorporated is seeking a Senior Project Manager/Senior Construction Manager to oversee large-scale K-12 facility improvement projects in Austin, Texas. The ideal candidate will possess strong construction administration and field coordination skills and...
- A leading education technology company is seeking a Strategic Account Director to lead growth across K-12 district customers in the U.S. This pivotal role includes managing enterprise accounts, driving the adoption of a multi-product platform, and establishing large-scale...
- A global leader in medical devices is seeking a Software Testing Lead in Austin, Texas. This role includes managing software verification and release strategies according to US FDA regulations. The ideal candidate will have extensive experience in software testing, team...Medical deviceFlexible hours
- ...transforming its development and regulatory processes to meet heightened... ...at scale. Qualifications · Medical degree (MD, DO, or equivalent... ...roles within medical device, digital health, or regulated... ...devices. · Proven track record leading cross-functional teams and serving...Medical device
- ...commercialization of advanced nuclear‑energy systems. We are seeking a Lead Recruiter to build and run our recruiting engine end‑to‑end.... ...regulated industries such as nuclear, aerospace, robotics, medical devices, or semiconductors. Proven ability to stand up recruiting...Medical device
- A medical device consulting firm is seeking an Associate for Regulatory Affairs. This role involves preparing regulatory submissions for medical devices, supporting international product registrations, and ensuring compliance with FDA and EU regulations. The ideal candidate...Medical deviceContract work
- ...ensuring compliance with standard operating procedures, and leading process improvement initiatives. The ideal candidate should... ...optimization techniques. Benefits include comprehensive medical coverage, 401(k) options, and tuition reimbursement. #J-18808-Ljbffr On-X...Medical device
$55k - $63k
The Child Development Center in Austin, Texas is looking for passionate Lead Threes and Pre‑K Teachers to join our team. As a NAEYC accredited preschool, we prioritize children's growth in a nurturing environment. This full-time position offers a competitive salary of $...Full time$55k - $63k
Full‑Time Lead Threes and Pre‑K Teachers - NAEYC Accredited Preschool The Child Development Center is looking for energetic, creative, and loving Lead Threes and Pre‑K Teachers to join our teaching team. We are NAEYC accredited and a 4‑Star Texas Rising Star preschool located...Full timeMonday to Friday
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