Regulatory Affairs Specialist II - Medical Devices (Hybrid)
Olympus Corporation
Olympus Corporation is hiring for a Regulatory Affairs role based in Massachusetts. The successful candidate will assist in obtaining marketing approvals and provide regulatory input for new product developments. Candidates should have at least 3 years of regulatory affairs experience in the Medical Device industry, preferably with a BS/BA in engineering or life sciences. Olympus offers a hybrid work environment and a comprehensive benefits package including medical coverage, paid vacation, and 401(k) matching. #J-18808-Ljbffr Olympus Corporation
$120k - $160k
...of their bodies and daily lives.WHOOP is looking for a Regulatory Affairs Specialist II, Expansion to be a core member of the Digital Health team... ...for global market access activities for Software as a Medical Device (SaMD), wearable technologies, and digital health...Medical deviceFull timeWork at officeRelocation- Siemens Healthineers AG is looking for a Regulatory Affairs Professional to join their team in Walpole, MA. This hybrid position entails preparing and maintaining regulatory... ...at least 2 years of experience in IVDs or medical devices. Strong knowledge of US/EU regulations and...Medical device
$90.1k - $153.3k
...automation solutions for Haemonetics' medical device software platforms. You will work closely... ...configuration of cloud resources (AWS, hybrid environments).Implement Infrastructure... ...with FDA, HIPAA, ISO 13485, and IEC 62304 regulatory requirements.Implement security-as-code...Medical deviceHourly payFull timeTemporary workMonday to FridayFlexible hours$101.44k - $126.8k
...About the Job: The Senior Specialist, Regulatory Affairs (CDx) performs activities to support the regulatory... ...of in vitro companion diagnostic medical devices in the US market. Write,... ...This position also qualifies for Foundation Medicine's benefits. #LI-Hybrid...Medical deviceFull timeWork experience placementWork at office$103.6k - $176.4k
...you to be onsite working a Hybrid schedule at 125 Summer Street... ...software development programs for medical device products in regulated... ...Software Engineering, Quality, Regulatory Affairs, Cybersecurity, Product... ...medical device products; Class II and/or Class III device experience...Medical deviceHourly payFull timeTemporary workSummer workMonday to FridayFlexible hours$103.6k - $176.4k
...position requires onsite work on a hybrid schedule at 125 Summer Street... ...product design history file, regulatory standards, and compliance to... .... Experience leading medical device development programs. Experience... ...device development (Class II/III) under FDA Quality Systems...Medical deviceHourly payTemporary workSummer workMonday to FridayFlexible hours$85k - $105k
Quality Assurance Specialist II, Device Engineering Location: Woburn, MA (relocating to a new facility... ...: Onsite 5 days/week with future hybrid flexibility following relocationCompensation... ...4+ years of quality experience within medical devices, combination products,...Medical deviceRelocation- ...their bodies and daily lives.WHOOP is looking for an Engineer II to join the Sensor Intelligence Group (SIG), a cross-functional... ...hemodynamics, thermoregulation, biochemistry)Experience in the context of medical device development, requirements definition, risk assessmentThis role...Medical deviceWork at officeRelocation
- ...efficient outcomes. Candidates should have at least a Bachelor's degree in Engineering and significant experience in product development and project management. The position offers hybrid workplace flexibility and competitive benefits. #J-18808-Ljbffr Olympus CorporationMedical device
$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs Specialist, UltrasoundThe Senior Regulatory Affairs Specialist for Ultrasound collaborates... ...Files, Declarations of Conformity, and Medical Device Licenses—for various global markets.Support...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$75.1k
...experience every day. The Quality Engineer II will utilize quality engineering... ...collaboration and synergy. This role follows a hybrid work model requiring employees to be in... ...● Minimum of 2 years' experience in the medical device industry or a similar regulated industry...Medical deviceHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week- ...Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent. Since 1996, MakroScientific’s proven staffing... ...Job Description This individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and...Medical device
$110k - $150k
...understanding of their bodies and daily lives. As a Mechanical Engineer II on the Hardware NPI Team at WHOOP, you will contribute to the... ...products, preferably for consumer electronics, wearables, or medical devices.Experience with SolidWorks CAD best practices, including...Medical deviceFull timeContract workWork experience placementWork at officeRelocation- Siemens Healthineers is seeking a Regulatory Affairs Professional in a hybrid role based in Walpole, MA. You will prepare and maintain regulatory submissions... ...requires a scientific degree, 2+ years in IVDs or medical devices, and strong document control and communication...Medical device
- ...systematic receipt, put away, replenish, pick, and shipment of medical devices, while identifying, resolving, or elevating issues in a... ...be in our local office five days per week. This role allows a hybrid work model, requiring employees to be in our local office at...Medical deviceWork experience placementWork at officeLocal area3 days per week
$147.4k
...therapeutic, diagnostic, drug delivery, genetic engineering, medical device, biomanufacturing, biomaterials and/or drug discovery technologiesPlease... ...a deal sheet and cover letter with application.This is a hybrid position. Tuesday and Wednesday are the TLO in-office core...Medical deviceFull timeWork at officeVisa sponsorship$103.6k - $176.4k
...visibility and decision-making. This is a hybrid flexible position with 10-15% travel.... ...initiatives, and proactively manage regulatory and operational risks. The Environment... ...Minerals, California Proposition 65, EU Medical Device Regulation (MDR) substance requirements...Medical deviceHourly payFull timeTemporary workMonday to FridayFlexible hours- Requisition ID: 65977 Title:Business Systems Analyst II- PLM DeveloperArthrex is a global medical device company and a leader in new product development and... ...and code reviews.Ensure solutions align with regulatory and compliance standards (e.g., FDA, ISO).Adhere to...Medical deviceWork experience placement
$260k - $360k
...Healthcare Regulatory Associate Attorney Date Posted: 08-04-2026 Job... .... Counsel drug, biologic, medical-device, diagnostics, food, dietary-... ...intellectual property, and other specialist teams. Conduct sophisticated... ...Work Model: Flexible hybrid; current team expectations to...Medical deviceWork at officeRemote workFlexible hours- ...Material Handler II Work mode: Onsite Onsite Location(s): Quincy, MA, US, 62301 Additional Location(s): N/A Diversity - Innovation... ...proper physical and systematic putaway and replenishment of medical devices, while identifying, resolving, or elevating issues in a timely...Medical deviceHourly payWork experience placementWork at officeLocal areaRelocation packageShift work
$160.6k - $240.8k
...areas to drive compliance with regulatory requirements to ensure the... ...clinical trials, understand medical terminology, standards of care... ...RequirementsPrior experience with medical device manufacture and transition to... ...much more.Flex Designation:Hybrid-Eligible Or On-Site...Medical deviceFull timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week- ...Description Job Description Associate Director, Regulatory Affairs Location: Boston, MA (Hybrid or East Coast, USA) Employment Type: Full-time,... ...other international submissions. Experience with medical device or combination product submissions. Understanding...Medical devicePermanent employmentFull time
$117k - $201.25k
...&V) Engineering Manager in a hybrid role to be based out of Raynham... ...critical part in supporting regulatory submissions and product... ...system test plans for complex medical devices, including system verification... ...Preferred:· Experience with Class II or Class III medical devices...Medical deviceFull timeLocal areaImmediate start- ...Minnesota, Brooklyn Park; Pennsylvania, Center Valley Workplace Flexibility: Hybrid Job Description Assist the Manager Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus. Job Duties Participate in product teams...Medical deviceLocal area
$175k - $225k
...growing, Boston-based medical technology company using... ...closely with R&D, Regulatory Affairs, Clinical and Product.... ...experience in the medical device industry and 2-5+... ...familiarity with FDA Class II devices and EU MDR... ...Boston, MA. Our team is hybrid and has a preference for...Medical deviceWork at officeLocal area- ...data management, biostatistics, medical writing, and pharmacovigilance... ...biopharmaceutical and medical device companies of all sizes. The Clinical Trial Associate II (CTA II) supports, coordinates... ...status: manage and track regulatory documentation, IND Safety Letter...Medical deviceWork experience placementWork at office
- ...Job Description Join Our Team at Tegra Medical! We’re a trusted contract manufacturer for... ...some of the biggest names in the medical device industry. Known for taking on complex projects... ...Job Summary The Swiss CNC Operator-II performs all tasks, roles and responsibilities...Medical deviceHourly payContract workMonday to FridayShift workDay shift
- ...Endoscopy-America seeks a CNC Machinist II for 2nd shift to produce precision components... ...for advanced endoscopic and surgical devices. You will set up, operate, and adjust CNC... ...perform in-process inspections to ensure tight medical-device tolerances. Responsibilities...Medical deviceAfternoon shift
- ...Job Overview: We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this role, you will play a vital part in... ...related area within the pharmaceutical, biotech, or medical device industries. ~ Familiarity with regulatory submission...Medical deviceContract workWork at office
- Siemens Healthineers seeks a Regulatory Affairs Professional (Finance) in Walpole, MA for a hybrid role. You will prepare/regulatory submissions for FDA/IVDR, support life-cycle documentation, and advise design control and product development teams. Lead technical files...Medical device
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