Senior Regulatory Affairs Specialist - Medical Devices
Medtronic plc
Medtronic plc is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategy for the Wound Management portfolio. You will work with the NPD team from opportunity through commercialization and ensure compliance for US and EU regulatory requirements. You will prepare 510(k) submissions, interact with the FDA, and support international registrations. You’ll review labeling, maintain documents, and contribute to internal audits and process improvements to keep pace with changing #J-18808-Ljbffr Medtronic plc
- A leading medical device firm in Connecticut is seeking a Senior Software Test Engineer to work within the R&D team developing robotic surgical systems. The ideal candidate will have over 5 years of experience in FDA regulated environments, proficiency in C++, and the...SeniorMedical deviceContract work
- ...development and validation, ensuring products meet quality and regulatory requirements while driving process improvements and... ...Roles & Responsibilities: Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies...SeniorMedical deviceRemote work
- Company DescriptionMedical Device Industry.Job DescriptionPerforms Quality Engineering functions in support of projects associated to... ...experience in design, manufacturing, or quality engineering position (medical device experience preferred). Three years of experience can be...SeniorMedical deviceFor subcontractor
- ...Responsible for supporting and improving packaging operations for medical device manufacturing. Lead packaging process development, equipment... ...(IQ/OQ/PQ). Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues...SeniorMedical deviceRemote work
$74.4k - $111.6k
...patients first - developing innovative medical technologies that improve the lives... ...the Life Medtronic is seeking a Regulatory Affairs Specialist to support the Wound Management Regulatory... ...support on a range of medical devices focusing on a diverse line of Sutures...Medical deviceH1bWork at officeLocal areaImmediate startFlexible hours$98.4k - $147.6k
...first — developing innovative medical technologies that improve the... ...in the medical device industry as a supplier quality... ...or process quality.TECHNICAL SPECIALIST CAREER STREAM: An individual... ...Influence: Communicates with senior internal and external customers...SeniorMedical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours- ...Senior Software Test EngineerJOB TITLE: Test Engineer III / Senior level Software Test Engineer CLIENT: A prominent Medical Devices Company. CONTRACT: 12 months contract (04/24/2017 to 04/23/2018) with a possibility of extension - possibility to be an employee based. LOCATION...SeniorMedical deviceContract workWork experience placementDay shift
$74.4k - $111.6k
...Regulatory Affairs Specialist Medtronic is seeking a Regulatory Affairs Specialist to support the Wound Management Regulatory Affairs team... ...candidate will provide regulatory support on a range of medical devices focusing on a diverse line of Sutures (absorbable/non-absorbable...Medical deviceH1bWork at officeLocal areaImmediate startFlexible hours- ...experience in DOE (with minitab) Other skills: 1. Computer and software validation CSV 2. SOP Development 3. Change control of Medical Devices 4. custom equipment validation experience Nice To Have1-3 years of Medical Device industry experience, Familiar with FDA 21 CFR...SeniorMedical deviceWork at office
$102.4k - $153.6k
...put patients first — developing innovative medical technologies that improve the lives of 72... ...growth, and impact.A Day in the LifeThe Senior Controls Manufacturing Engineer provides... ...manufacturing environments such as medical device or pharma Familiarity with equipment...SeniorMedical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$82k - $131.5k
...talents and contributions are welcome. Discover your opportunities at Yale!OverviewReporting to the Regulatory Affairs Manager, the Senior Regulatory Affairs Specialist independently leads regulatory activities for Yale Cancer Center Clinical Trials Office clinical research...SeniorInterim roleWork at officeLocal area- ...job poster from Planet Pharma Overview Our client, a leading Medical Device company, is seeking an experienced Quality Engineer to join their... ...Verification Authoring and Execution Responsibilities The Senior Quality Engineer position on the team supports new product development...SeniorMedical deviceContract work
- ...Senior Risk Management Quality Engineer Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and... ...product development, design controls and regulatory compliance within the medical device industry. This position requires a...SeniorMedical device
- ...Haven, CT Remote/Onsite: Onsite Benefits: Medical, Dental, Vision, 401K plan, PTO Job Type... ...packaging operations for medical device manufacturing. Lead packaging process development... ...with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve...SeniorMedical deviceFull timeContract workLocal areaRemote work
- ...The Senior Quality Engineer will support the site's transition... ...Quality, R&D, Manufacturing, Regulatory, IT), reviewing and approving... ...product or process quality SPECIALIST CAREER STREAM: Typically an... ...Management: Strong experience with medical device quality systems, including...SeniorMedical deviceFlexible hours
$130k
...Senior Manufacturing EngineerTrillium Professional is now seeking... ...metals-based solutions for top medical Original Equipment... ...adherence to ISO 13485 and FDA regulatory standards.Costing & Quote Development... ..., ideally within medical device contract manufacturing or high...SeniorMedical deviceContract workRelocation packageFlexible hoursDay shift$165k - $185k
...Description Vice President of Engineering / Senior Electrical Engineer Location: Shelton,... ...and magnetic solutions for utility, medical, marine, datacenter, energy-storage, industrial... ..., datacenters, energy storage, medical devices, marine systems, and industrial power....SeniorMedical deviceFull time- ...Description Job Description Description: Senior Project & Manufacturing Engineer Full-... ...Hobson & Motzer is now part of Vantedge Medical! Vantedge Medical is the premier metals-... ...serving the needs of the medical device market and other advanced industries. We...SeniorMedical devicePermanent employmentFull time
- ...agencies on this role. About Us: Vantedge Medical is the premier metals-based med-tech... ...leader within a regulated medical device and AI data center manufacturing environment... ...automation and controls Serve as the senior technical authority for robotics, PLC / controls...SeniorMedical devicePermanent employmentFull timeWork at office
- ...seeking a Quality Engineer II to support Surgical Sutures Manufacturing. The role focuses on maintaining quality standards, ensuring regulatory compliance, and collaborating with engineering and manufacturing to improve processes. The ideal candidate will hold a Bachelor’s...Medical device
$98.4k - $147.6k
...patients first — developing innovative medical technologies that improve the... ...a highly skilled and experienced Senior Risk Management Quality Engineer to... ...development, design controls and regulatory compliance within the medical device industry. This position requires a...SeniorMedical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$107.2k - $160.8k
...put patients first — developing innovative medical technologies that improve the lives of 72+... ...and testing. This role also supports medical device product development, and a solid understanding of design controls and regulatory compliance requirements is preferred. This...SeniorMedical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$105k
...developing innovative medical technologies that improve... ...collaboration with senior Territory Managers and... ..., acting as a therapy specialist and resource. Execute... ...all company policies, regulatory guidelines, and... ...roles within medical devices, medtech, healthcare,...SeniorMedical deviceContract workH1bWork at officeLocal areaImmediate startRemote workFlexible hours- ...activities. Ensure manufacturing processes comply with applicable regulatory and quality requirements. Lead moderately complex engineering... ...Transfer. Continuous Improvement. Regulated Manufacturing. Medical Device / Pharmaceutical Manufacturing. Quality & Regulatory...Medical device
- ...Regulatory Affairs Specialist Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our...
$134.4k - $201.6k
...first — developing innovative medical technologies that improve the... ...and Development, Quality, Regulatory, Marketing, Manufacturing, and... ...Development, Quality, Regulatory Affairs, Manufacturing, Marketing,... ...Experience within the medical device industry supporting wound...Medical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$260k - $300k
...everything possible.The Senior Director, Medical & Scientific Affairs - Specialty Testing is responsible... ..., a team of medical specialists dedicated to all medical... ...product development, regulatory submissions, and... ...medical technology, medical device, or pharmaceutical industry...SeniorMedical deviceFull timeRemote workWork from homeFlexible hours- ...method development Must Have: Minimum Requirements* Bachelors degree requiredNice to Have Basic knowledge of medical device industry including clinical and regulatory pathways. Outstanding written and verbal communication/listening skills. Detail-oriented with strong...Medical device
$89.82k - $121.6k
...transforming your career. Specialty Representative/Senior Specialty Representative - Cardiovascular... ...clinical knowledge of our products to medical professionals and helping them navigate... ...pharmaceutical, biotech or medical device industry Product or hospital sales experience...SeniorMedical deviceFull timeLocal areaRemote workFlexible hours- ...Job Title: Technician I Client: Medical Device Manufacturing Company Duration: 9 months Location: North Haven, Connecticut 06473 Technical Skills Must Have: Nice To Have: Demonstrated use of Microsoft Tools (Excel, PowerPoint, Word) or other...Medical deviceImmediate start
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Specialist - Medical Devices. Be the first to apply!
- senior application security North Haven, CT
- senior North Haven, CT
- senior customer success engineer North Haven, CT
- senior operations technician North Haven, CT
- senior device engineer North Haven, CT
- senior vmware engineer North Haven, CT
- senior resident engineer North Haven, CT
- senior implementation engineer North Haven, CT
- senior performance engineer North Haven, CT
- senior tech North Haven, CT


