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
- ...Job title: Regulatory Affairs Specialist Location: Mansfield, MA Duration: 5+ months (possibility of extension) Roles and Responsibility The... ...development teams, familiarity with FDA regulations for medical devices, submission experience of 510(k)s, generation of files necessary...Medical device
$101.5k - $152.25k
...takes the limits off living. Are you a regulatory affairs professional who enjoys working at the... ...a key role in supporting life changing medical technologies used by patients around... ...strategies for new and modified medical devices Preparing and managing regulatory submissions...Medical deviceLocal areaFlexible hours- ...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
- 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
- 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
- Dormont Manufacturing Co is looking for a Regulatory Affairs (RA) Specialist in Bridgewater, Massachusetts. This role involves supporting regulatory submissions and compliance to ensure medical device products meet applicable regulatory requirements. The ideal candidate...Medical device
$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- 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
- About Spectrum Vascular Spectrum Vascular is an innovative medical device company focused on vascular access and medication... ...and an entrepreneurial mindset. Role Description The Regulatory Affairs (RA) Specialist is responsible for supporting global regulatory submissions...Medical deviceInternshipWork at officeWorldwide
$62.1k - $85.1k
...compliance activities in accordance with internal procedures and regulatory requirements. Primary responsibilities include supporting... ...years of experience working within a regulated industry (e.g., medical device, pharmaceutical, biotechnology, or similar).Previous...Medical deviceTemporary work- ...Control Coordinator in Mansfield, MA to manage the document control program ensuring compliance with domestic and international medical device regulations. You will coordinate, process, and maintain controlled documents and training records within the QMS, supporting...Medical device
- ...Massachusetts, to contribute to the design and development of DVT prevention devices. The ideal candidate will have a degree in Electrical or Biomedical Engineering, with 5+ years of medical device experience. Strong skills in PCB design software and knowledge of medical...Medical device
- Stark Pharma Solutions Inc is recruiting a Packaging Engineer III to support product development and packaging design for medical devices. The role requires strong expertise in packaging and validation processes, ensuring compliance with industry standards. The ideal candidate...Medical device
- Smith & Nephew in Mansfield seeks a Packaging Engineer to design and develop both sterile and non‑sterile packaging systems for innovative sports medicine technologies. The ideal candidate will have a Bachelor's degree in Packaging Engineering and at least 2 years of experience...Medical device
- ...Mansfield, Massachusetts. This role focuses on hands-on injection molding processing, mold maintenance, and production support for medical devices. Candidates should have a Bachelor's degree in Plastics Engineering and 2+ years of relevant experience. The Engineer will lead...Medical device
$50 - $60 per hour
...Manufacturing Engineer for a contract role based in Massachusetts. The successful candidate will generate and execute validation plans for medical devices, ensuring compliance with FDA and international regulations. Candidates should have a B.S. in Engineering and 7+ years in the...Medical deviceHourly payContract work- ...diverse teams to meet milestones. The role values technical curiosity, execution, and strong communication. A Bachelor's in science/engineering and at least 2 years in NPD, plus exposure to medical devices and plastics, will help you succeed. #J-18808-Ljbffr Smith+NephewMedical device
- Paragon Medical in Mansfield, MA is seeking a Quality Inspector to test materials and finished products, ensuring conformity to applicable standards. You will verify quality across incoming, in-process and final stages while reporting to the Quality Manager. Responsibilities...Medical device
- ...leading healthcare firm is looking for a Design Quality Engineer to ensure quality excellence in the development life cycle of medical devices. This role involves collaborating with cross-functional teams for design control processes, managing risk documentation, and resolving...Medical device
- A leading medical device company located in Massachusetts is seeking a Senior Engineer I, Quality Design Assurance to drive the quality development... ...cross-functional teams, leading risk analysis, and ensuring regulatory compliance throughout product development. Ideal candidates...Medical device
- A global medical device company is seeking a Staff Design & Reliability Assurance Quality Engineer to lead critical risk management activities. This role demands 8 years of experience in a regulated industry, preferably within medical devices, and requires expertise in...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 areaImmediate startFlexible hours- ...Pennsylvania Job Overview The Sr. Source Regulatory Compliance Specialist is responsible for executing and... ...closely with Quality, Regulatory Affairs, Supply Chain, and Procurement... ...detail. Preferred Experience in medical devices, healthcare, or other highly regulated...Medical deviceContract workLocal area
$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$68.5k - $97.8k
...the design and development life cycle of medical devices. This function ensures robust design... ...and processes to ensure compliance with regulatory standards, and achievement of long‑term... ...Research and Development, Regulatory, Medical Affairs and Quality Operations teams to ensure...Medical deviceTemporary workLocal areaImmediate startFlexible hours- ...Acclaro Corporation Acclaro Corporation is a pioneering medical device company specializing in innovating, developing, and bringing... ...collective team! About The Role As a Digital Marketing Specialist in our Marketing department, you will be a key driver of...Medical deviceFull time
$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 deviceVisa sponsorship- Collabera is seeking a Regulatory Affairs Manager for a 6+ month engagement to guide compliance with FDA... ...ISO and other standards across diverse device projects. Required are a science/engineering degree, 5+ years in medical device regulatory affairs, and experience...Medical device
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