Global Regulatory Affairs Specialist II — Medical Devices
Cook Medical
Regulatory Jobs seeks a Regulatory Affairs Specialist II to coordinate regulatory submissions for medical devices across global markets and to develop regulatory strategies, maintaining approvals with the manufacturing team and local regulatory offices. The role requires up-to-date knowledge of ISO 13485, MDR 2017/745, FDA 21 CFR Part 820, and related regulations, as well as preparing change requests and supporting post-market activities with excellent documentation practices. #J-18808-Ljbffr Cook Medical
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Specialist II — Medical Devices in Vandergrift, PA vacancy
- ...Regulatory Affairs Specialist II The Regulatory Affairs Specialist II is responsible for the planning... ...approvals for new and modified medical devices in specific markets. The Regulatory... ...Maintain an excellent understanding of global medical device regulations...Medical deviceWork at officeLocal areaAfternoon shiftEarly shift
Cook Vandergrift
Vandergrift, PA2 days ago - Cook Vandergrift in Vandergrift, PA, is seeking a Regulatory Affairs Specialist II (Finance) to plan and prepare submissions for regulatory approvals of medical devices. You will develop regulatory strategies and act as liaison between the Cook manufacturer and the local...Medical deviceWork at officeLocal area
- ...Description: The Supplier Quality Specialist will support supplier... ...functional teams to support regulatory compliance, quality... ...Experience supporting medical device manufacturing or other highly... ...Experience working with global suppliers and cross-functional...Medical device
Katalyst Healthcares & Life Sciences
Delmont, PA19 days ago - ...documentation, inspection, and quality systems. Ability to work in manufacturing and regulated environments. Preferred Experience Medical Device manufacturing environment. Experience supporting production transfers, validation execution, or supplier quality activities....Medical device
Katalyst CRO
New Kensington, PA2 days ago - ...important part in supporting the firm's regulatory compliance program, helping ensure adherence... ...of experience in compliance, regulatory affairs, audit, operations, or the financial... ...financial institutions and start-ups to global public firms and middle-market companies...SuggestedWork at officeLocal areaWorldwide
The Prosperity Consulting Group LLC
Saltsburg, PA1 day ago - ...Perform product safety testing to applicable global standards, including IEC 60601-1 and... ...with engineering, compliance, regulatory, product development, manufacturing, and... ...highly preferred. You have knowledge of medical device standards, and experience with wireless...Medical deviceHourly payFull timeWork visaRelocation package3 days per week
$102k - $163k
...Lead product safety and compliance activities for medical devices, helping ensure products meet regulatory requirements and internal quality standards throughout... ...Philips, we believe that every human matters. As a global health‑tech leader, we focus on improving people’s...Medical deviceFull timeWork at officeWork visaRelocation package3 days per weekPhilips
New Kensington, PA13 hours ago- ...cross-functional teams to ensure compliance with quality and regulatory requirements throughout the transfer lifecycle. Support... ...5 years of Supplier Quality Engineering experience in Medical Devices or other regulated industries. Hands-on experience with APQP...Medical device
Katalyst Healthcares & Life Sciences
Delmont, PA19 days ago - ...environments. Strong documentation, organizational, and problem-solving skills. Preferred Qualifications: Experience in the medical device or other regulated manufacturing industry. Exposure to manufacturing transfers, process validation, supplier quality, or new...Medical device
Katalyst Healthcares & Life Sciences
New Kensington, PA17 days ago - ...and Safety/Compliance is a must. ASQ certifications (CQE, CRE, CMQ/OE etc) Preferred. Strong understanding of medical device industry regulatory requirements including but not limited to MDSAP participating countries, ISO Standards (ISO 13485 and ISO 14971), EUMDR...Medical device
Karwell Technologies
New Kensington, PA19 days ago - ...required to hold ASSE (American Society of Sanitary Engineering) certifications, such as ASSE 6040 and ASSE 6030 (Medical Gas System Verifier).Regulatory Knowledge: Deep understanding of NFPA 99 (Health Care Facilities Code) and local plumbing or mechanical codes.Background...Local areaAfternoon shift
Medpipe Maintenance Corp
Natrona Heights, PA2 days ago $102k - $163k
...Care technologies to patients around the world.Your role:Lead product safety and compliance activities for medical devices, helping ensure products meet regulatory requirements and internal quality standards throughout the product lifecycle. You will support safety...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per weekPhilips
New Kensington, PA2 days ago$102k - $163k
...respiratory ventilators and sleep therapy devices, ensuring our Sleep & Respiratory Care (... ..., reliability, and manufacturability), regulatory requirements, and system architecture... ...+ years successfully developing complex medical devices and a focus in systems engineering...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per weekPhilips
New Kensington, PA2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Affairs Specialist II — Medical Devices. Be the first to apply!
