Global Regulatory Affairs Principal Leader - Medical Devices
Werfen
Werfen is seeking a Senior Principal Regulatory Affairs Specialist to support regulatory affairs and quality systems for US, Canada, and EU markets. You will drive submissions (510(k), BLA), maintain technical files, and ensure compliance across global regulatory requirements. The ideal candidate has 8+ years in medical device regulatory affairs, with strong knowledge of FDA and EU regulations, ISO 13485, and risk management frameworks. #J-18808-Ljbffr Werfen
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Principal Leader - Medical Devices in Norcross, GA vacancy
- Werfen is seeking a Senior Principal Regulatory Affairs Specialist to support regulatory affairs and quality systems across the US, Canada, and... ...have 8+ years of regulatory affairs experience in medical devices, strong knowledge of FDA and EU regulations, and a solid...PrincipalMedical device
- Werfen is seeking a Senior Principal Regulatory Affairs Specialist to lead regulatory... ...(510(k), BLA, and device licenses) and maintain technical... ...ensuring compliance with SOPs and global standards. The role... ...regulatory affairs experience in medical devices and strong...Medical device
- ...Senior Principal Regulatory Affairs Specialist As a Senior Principal Regulatory Affairs Specialist, you will perform regulatory affairs and... ...and submission of product applications (510(k), BLA, Medical Device Licence Applications/Amendments, and Technical Documentation...PrincipalMedical device
- Barco is seeking a Global Partner Manager to manage and grow key OEM relationships within... ...and business development within the medical device or healthcare marketExperience in mammography... ...to work for an international market leader where innovation mattersAccess to internal...Medical device
$99.3k - $198.7k
...Strategic Pricing & Contracting, Project Management Office Leader (PMO) Abbott is a global healthcare leader that helps people live more fully at... ..., with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,00...Medical deviceContract workWork experience placement- Avanos Medical seeks an R&D Principal Engineer to lead development of advanced medical devices that improve patient outcomes in pain management... ...with clinical, quality, regulatory, and manufacturing teams, you... ...innovation, reliability, and patient safety across global programs.PrincipalMedical device
Avanos Medical
Alpharetta, GA13 days ago - Avanos Medical seeks a Principal Quality Systems Engineer to own and enhance our global Quality Management System (QMS) supporting class II/III medical devices. In this role, you will lead QMS strategy, implementation... ...14971 and other global regulatory requirements. You will...PrincipalMedical device
Avanos Medical
Alpharetta, GA13 days ago - ...Key Account Manager - Global Partner Location: Duluth, GA, US Barco is seeking a Global... ...and business development within the medical device or healthcare market ~ Experience in mammography... ...to work for an international market leader where innovation matters Access to...Medical device
- ...governing and enforcing Intuitive's global trade compliance framework for medical devices, instruments, accessories,... ...supporting uninterrupted patient care, regulatory approvals and global commercial... ..., etc. Partner with Regulatory Affairs and Quality to ensure trade...Medical deviceLocal areaFlexible hours
- Avanos Medical seeks a Principal Design Quality Assurance Engineer to lead design transfer of medical devices from development to manufacturing. In this role, you will own design quality... ...closely with R&D, operations, and regulatory teams to establish robust technology transfer...PrincipalMedical deviceWorldwide
Avanos Medical
Alpharetta, GA13 days ago - ...Regulatory Affairs Specialist CorDx, a multi-national biotech organization, focused on pushing... ...limits of innovation and supply in global health. With over 2000 employees across... ...delivers rapid testing and point-of-care medical device solutions used in the detection of...Medical device
- ...Hiring: Fulfillment Manager (Medical Devices) Location: Sandy Springs /Norcross (Local Candidates Only Please) Type: Full-time Direct Team... ...direct reports (Customer service, warehouse, distribution) A global medical device company looking for a Fulfillment Manager to lead...Medical deviceFull timeLocal area
GSI, Inc
Peachtree Corners, GA3 days ago - ...A leading company in the Medical Equipment Manufacturing industry is seeking a Global Marketing Product Manager to drive new product development and support Transfusion revenue growth on a global scale. The ideal candidate will collaborate with cross-functional teams,...Full time
Werfen North America
Peachtree Corners, GA5 days ago - ...strategies, activities, and requirements for the medical devices import, export, and trade regulations. He... ...to cross-functional teams. Support global and regional compliance projects and programs. Customs, Tariffs & Regulatory Programs Manage issues related to:...Medical deviceLocal area
- ...10,001+ Categories Medical Care Manufacturing Medical Devices Medicine Specialties... ..., and enforcement of a global trade compliance... ...role demands a strategic leader who can proactively advise... ...assess geopolitical and regulatory developments, and embed...Medical device
$149.5k - $253.1k
...everything we do at Intuitive . As a global leader in robotic-assisted surgery and... ...responsible for implementing legal and regulatory requirements into practical processes... ..., life sciences, academic research or medical device. Advanced degree in law, risk management...Medical deviceFull timeWork at officeLocal areaWorldwideFlexible hoursShift work3 days per week- ...Overview: The Senior Director, Regulatory Affairs is responsible for leading the global regulatory strategy for the... ...orthopedic products, including medical devices, biologics, combination products... ...and pipeline technologies. This leader will develop and execute...Medical deviceFull timeContract workWork at officeLocal area
Kuros Biosciences, Inc.
Alpharetta, GA4 days ago - ...programs, including but not limited to, global import and export classification,... ...and conducting audits for accuracy and regulatory adherence. Monitor inquiries from Customs... ...export restrictions and communicate back to medical device business. Submit and monitor import/...Medical deviceWork experience placementWork at officeFlexible hours
- ...Chicago, IL; Atlanta, GA; or Morrisville, GA. Travel up to 25% is required. The role requires a 4-year degree in physical science or engineering and 10+ years experience in quality/regulatory compliance, with demonstrated leadership of #J-18808-Ljbffr Univar Solutions
- ...Compliance SpecialistAt Avanos Medical, we passionately believe in... ...world. Avanos is a medical device company focused on... ...communicating changes in the global regulatory and quality standards landscape... ...including Quality, Regulatory Affairs, R&D, Sustaining Engineering...Medical device
Avanos
Alpharetta, GA4 days ago - ...Job Description Job Description Global Market Development Leader – Thermal Industrial About Arclin You can find Arclin everywhere. Our technologies make homes and transportation safer, help crops flourish, keep water clean, protect first responders and members of...
Arclin USA LLC
Alpharetta, GA13 days ago - ...everything we do at Intuitive. As a global leader in robotic-assisted surgery... ...Lean Manufacturing principals, and identify and... ...experience in the Pharmaceutical or Medical Device industry (or similar regulated... ...knowledge of ISO and regulatory restrictions.Additional InformationDue...Medical deviceLocal areaWorldwideFlexible hours
Intuitive
Peachtree Corners, GA5 days ago - Jolly Elementary School in Georgia is seeking a motivated and experienced Assistant Principal to lead instructional programs and school operations in a dynamic district. The successful candidate will develop short- and long-term goals aligned with the district's strategic...PrincipalTemporary work
- ...and maintain effective communication with team members and management. Candidates should possess a BS in a STEM field and have at least 7 years of relevant experience in project or product development, particularly in the medical device sector. #J-18808-Ljbffr WerfenMedical device
$68k - $108k
...effectively with diverse groups. We need experience working in a global organization across the full SDLC, including requirements,... ...Support SAP Web Excel More: We are Avanos Medical, a medical device company focused on delivering clinically superior...Medical deviceFull timeImmediate startWorldwideAvanos Medical
Alpharetta, GA4 days ago- ...Regulatory Affairs Specialist We are seeking a knowledgeable and detail-oriented Regulatory... ...of pharmaceutical, biotechnology, or medical device products. The ideal candidate will prepare... ...submissions, ensure compliance with global regulatory requirements, and collaborate...Medical deviceWork at officeLocal areaFlexible hours
- ...Requisition ID: 7081 Job Title: Global SAP Development Lead Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making... ...to excel and to help change what medical devices can deliver, now and in the future....Medical deviceFor contractorsImmediate start
Avanos Medical
Alpharetta, GA1 hour ago - ...integrity, noise immunity, and compatibility with industry standards.Principal Liaison: Liaise between Analog Design Team and Verification/... ...driven by its Purpose, To Make Our Lives Easier. With a global team of over 21,000 engineers and problem solvers in more than...Principal
- ...experienceAdditional InformationRenesas is an embedded semiconductor solution provider driven by its Purpose, To Make Our Lives Easier. With a global team of over 21,000 engineers and problem solvers in more than 30 countries, we offer the opportunity to work on world‑leading...Principal
- Job Summary:As leader of the card solutions product line, clearly communicate and drive product strategy, direction, and vision; maintains... ..., Product Marketing Managers, Project Managers, Architects, Global Solution Consultants and Quality Assurance.External: Extensive communications...PrincipalContract workWork experience placement
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Affairs Principal Leader - Medical Devices. Be the first to apply!
Related searches
- key team leader Norcross, GA
- compliance team leader Norcross, GA
- focus group leader Norcross, GA
- team lead data science Norcross, GA
- disability team leader Norcross, GA
- team supervisor Norcross, GA
- team leader mental health Norcross, GA
- quality control team lead Norcross, GA
- integration team lead Norcross, GA
- leader Norcross, GA