Medical Device Regulatory Affairs Specialist
Collabera
A leading IT staffing firm in Mansfield, Massachusetts is seeking a professional for a role in regulatory affairs. The candidate will be responsible for preparing and auditing medical device DHFs and risk management files while ensuring compliance with US and international regulations. The ideal applicant should have hands-on experience in technical file preparation and a keen understanding of regulatory standards. This position offers a favorable benefits package, including medical and retirement plans. #J-18808-Ljbffr Collabera
$101.5k - $152.25k
...takes the limits off living. Are you a regulatory affairs professional who enjoys working at the... ...akey role in supporting life changing medical technologies used by patients around the... ...strategies for new and modified medical devices Preparing and managing regulatory submissions...Medical deviceLocal areaFlexible hours- A professional staffing agency is seeking a Regulatory Affairs Specialist in Mansfield, MA. The ideal candidate will have experience working with... ...teams and must be knowledgeable in FDA regulations and medical device submissions. This role involves providing regulatory...Medical device
- ...paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K... ...Disability Insurance. Job Description Regulatory affairs with Technical Files, or equivalent in... ...preparation, review, and/or auditing of medical device DHFs, Risk Management files, and/or DMR...Medical devicePermanent employment
- Job title: Regulatory Affairs Specialist Location: Mansfield, MA Duration: 5+ months (possibility of extension) Roles and Responsibility The skills... ...development teams, familiarity with FDA regulations for medical devices, submission experience of 510(k)s, generation of files...Medical device
- Regulatory Affairs Manager / Regulatory Affairs Specialist role Established in 1991, Collabera has been a leader in IT staffing... ...submissions which may include device 510(k), IDEs, PMAs) and serving... ...field preferred. 5+ years of medical device regulatory affairs experience...Medical devicePermanent employmentLocal area
- Spectrum Vascular in Bridgewater, Massachusetts is looking for a Regulatory Affairs Specialist to support global regulatory submissions and ensure compliance with medical device regulations. The ideal candidate has a Bachelor's degree in a scientific field and 1-3 years...Medical device
- Siemens Healthineers AG is looking for a Regulatory Affairs Professional to join their team in Walpole, MA. This hybrid position entails... ...discipline and at least 2 years of experience in IVDs or medical devices. Strong knowledge of US/EU regulations and good attention...Medical device
- Overview Spectrum Vascular is an innovative medical device company focused on vascular access andmedication management. Our mission... ...mindset. Role Description Role Description: dThe Regulatory Affairs (RA) Specialist is responsible for supporting global regulatory submissions...Medical deviceInternshipWork at officeWorldwide
$80 - $100 per hour
...$100.00/hr Kelly Science & Clinical is seeking a Regulatory Specialist for our client, a leading medical device company based in Bridgewater, NJ. If you’re passionate... ...to products. Works closely with the Regulatory Affairs labeling group in order to assess and determine...Medical deviceFull timeFixed term contractRemote workMonday to Friday$20 per hour
Adecco Staffing is seeking experienced Assemblers in Mansfield, MA. This role involves assembling and packaging medical devices in a GMP-regulated environment. Preferred candidates will have manufacturing experience and a high school diploma. The position offers a weekday...Medical deviceHourly payShift workWeekday work$66.5k - $88.02k
...What Regulatory Affairs contributes to Cardinal Health Regulatory provides... ...to enable pharmaceutical, medical and biotechnology companies... ...The Sr Regulatory Affairs Specialist will support the Medical Solutions... ...portfolio of medical devices. This could include support...Medical deviceFull timeTemporary workWork experience placementWork at officeLocal areaImmediate startRemote workFlexible hours$90k - $125k
NextPhase Medical Devices LLC is seeking a Quality Engineer in Mansfield, MA. The role involves ensuring compliance with FDA regulations and ISO standards while supporting product development efforts. Ideal candidates will have a Bachelor's in Engineering or Quality Assurance...Medical device- ...seeking an Advanced Manufacturing Engineer to support new product introductions and develop manufacturing processes for innovative medical devices. This role is critical in launching Sports Medicine products that improve patients' lives. The successful candidate will have a...Medical deviceFlexible hours
- Smith & Nephew is seeking a Manufacturing Engineer II in Mansfield, MA, to focus on injection molding for medical device production. This pivotal role involves hands-on process optimization, mold maintenance, and collaboration on design for manufacturability. The ideal...Medical device
- ...enhance product reliability and quality. The ideal applicant will have at least 3 years of experience in quality assurance in the medical device field, a Bachelor’s degree in a related discipline, and proficiency in various computer tools. At Teleflex, we offer a...Medical device
$81.65k - $112.7k
...Senior Engineer, Quality Design Assurance, to drive the development of medical devices. This role involves collaboration with R&D, conducting risk analyses, and ensuring compliance with regulatory standards. With a focus on quality and efficiency, candidates should have...Medical device- ...existing product lines. Applicants should have a Bachelor’s degree in Packaging Engineering, with significant experience in the medical-device sector. Qualified candidates will collaborate with various teams and lead packaging activities throughout the product lifecycle...Medical device
- ...design and development initiatives, covering the entire product life cycle. The successful candidate will ensure compliance with medical device regulations and collaborate with teams across the USA, Asia, and Latin America. The role requires a Bachelor’s degree in...Medical device
- ...ensuring product design compliance with regulatory and quality requirements. The role... ...with R&D, Manufacturing, and Regulatory Affairs while managing design controls, risk management... ...and 2-5 years of experience in medical device quality or design assurance. Excellent...Medical device
- Hobbsnews is seeking a Sr. R&D Engineer to oversee new and existing product development in the medical device field. The position involves leading projects, ensuring compliance with regulations, and managing cross-functional teams across multiple locations. The ideal candidate...Medical device
- ...constructs, process validations, and product improvements. The ideal candidate will have at least 6 years of experience in the medical device field, strong project management skills, and knowledge of FDA and ISO standards. This position offers a competitive salary and...Medical device
$90.2k - $115.83k
...working knowledge of regulations for the medical device industry are essential. Schedule:... ...and thoughtfully incorporate required regulatory medical device standards (FDA, ISO, IEC... ...Quality Engineering (DQE), Regulatory Affairs (RA), Manufacturing, and other technical...Medical deviceTemporary workWork at officeLocal areaFlexible hours$78k - $117k
...Smith+Nephew we design and manufacture technology that takes the limits off living.Are you passionate about bringing innovative medical devices to life? Join our Global Operations Advanced Manufacturing Engineering team and play a critical role in launching new Sports...Medical deviceFlexible hours$71.3k - $97.75k
...Administration regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.**KEY RESPONSIBILITIES*** Work cross-functionally with EHS, product development, process...Medical deviceTemporary work$74.25k - $111.5k
...injection molding processing and mold maintenance to support medical device production. This role requires a strong background in scientific... ...CAD software (SolidWorks/AutoCAD).* Experience with medical regulatory requirements (GMP/ISO 13485).Physical Demands: Ability to...Medical deviceFlexible hours- NextPhase Medical Devices LLC is seeking a Quality Electronics Technician II in Mansfield, MA. This role involves ensuring product quality through inspection and testing of medical device products. Applicants should have experience in regulated manufacturing environments...Medical device
- Infoway Group in Mansfield, Massachusetts is seeking a candidate to support the Post Market Vigilance Investigations team in the Patient Monitoring and Recovery Division. Responsibilities include managing physical complaint products, coordinating investigations, and performing...Medical device
- A leading medical device firm in Massachusetts is seeking candidates for a role focused on coordinating the remediation work at their site. The position requires extensive experience in medical device and design control. Candidates should have a BS in science or engineering...Medical device
- NextPhase Medical Devices LLC is hiring a Production Supervisor in Mansfield, MA. In this role, you will oversee production assembly tasks to ensure quality and schedule adherence while mentoring a high-performing team. The ideal candidate has over 5 years of experience...Medical device
- ...science or engineering or equivalent experience. 5-7 or more years of experience. Will consider more senior level candidates. Medical device and design control experience is required. Summary of Position Coordinate the remediation work for the site while working with...Medical device
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