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 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
- Overview Job Summary As a Senior Principal Regulatory Affairs Specialist, you will perform regulatory affairs and quality system support activities... ...and submission of product applications (510(k), BLA, Medical Device Licence Applications/Amendments, and Technical...PrincipalMedical device
- ...and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research... ...staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing...Medical deviceContract work
HonorVet Technologies
Duluth, GA4 days ago - ...Global Product Owner for customer service technology platforms at a medical device company. Translates business strategy into scalable product roadmaps for Salesforce Service... ...ability to influence cross-functional leaders and drive alignment without direct authority...Medical device
- Lightera is seeking a Master Data Manager to lead the global MDM strategy and governance across ERP, MES, PLM, CRM, and analytics platforms. This senior role partners with Finance, Operations, and IT to establish a single source of truth across the enterprise, ensuring...Suggested
- ...Function of Position The Senior Manager Global Trade Compliance Trade Programs is... ...conducting audits for accuracy and regulatory adherence. Monitor inquiries from Customs... ...restrictions and communicate back to medical device business. Submit and monitor import/...Medical deviceFull timeWork experience placementWork at officeLocal areaRemote workFlexible hours
- Werfen seeks a marketing professional to support the Product Manager and Marketing Director in defining market requirements for Transplant products. You will prepare marketing materials, coordinate with R&D, Operations, and field teams, and help train the commercial staff...Medical device
- Agiliti Health, Inc. is seeking a Medical Equipment Technician I in the Atlanta District... ...perform cost-effective maintenance on medical devices, inspect, calibrate, and repair... ...specs, and document work for billing and regulatory compliance. The role requires a high school...Medical deviceFlexible hoursAfternoon shift
- Axis is looking for a lead architect who blends bold aesthetics with technical excellence. You will shape the firm’s design language and lead a team of architects and designers. You will work with our interdisciplinary team to ensure projects are visually striking, buildable...PrincipalFull time
- 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
- ...Marketing Strategy Analyst role supporting marketing leadership at a medical device company. The position involves analyzing complex business data... ...Support budgeting, forecasting, and headcount planning for Global Marketing Requirements ~5+ years of analytical experience...Medical device
Intuitive Surgical
Peachtree Corners, GA5 days ago - ...the limits of innovation and supply in global health. With over 2,100 employees across... ...rapid testing and point-of-care medical device solutions used in the detection of infectious... ...Management Ensure adherence to all regulatory requirements and company policies. Identify...Medical deviceFull time
CorDx
Alpharetta, GA26 days ago - ...leading automotive company located in Norcross, Georgia, is seeking a Senior Compliance Analyst to lead product development and ensure regulatory compliance. The role emphasizes team collaboration, mentoring, and attention to detail. Ideal candidates will have 5-7 years of...
- ...the limits of innovation and supply in global health. With over 2000 employees... ...delivers rapid testing and point-of-care medical device solutions used in the detection of infectious... .... Position Summary The Regulatory Affairs Specialist will support the preparation...Medical deviceFlexible hours
CorDx
Alpharetta, GA17 days ago - ...Description Job Description Job Description Regulatory Affairs Specialist Job Title: Regulatory... ...of pharmaceutical, biotechnology, or medical device products. The ideal candidate will... ...submissions, ensure compliance with global regulatory requirements, and collaborate...Medical deviceWork at officeLocal areaRemote workFlexible hours
Ova Technologies
Alpharetta, GA4 days ago - ...Principal Analog Design Engineer Job Description Architect, design and verify CMOS analog blocks for custom ASICs to meet stringent... ...driven by its Purpose, To Make Our Lives Easier . With a global team of over 21,000 engineers and problem solvers in more than...PrincipalRemote work
Renesas
Duluth, GA5 days ago - Stratix Corporation is seeking a Quality Assurance (QA) Specialist to ensure provisioning, configuration, and kitting of medical devices meet regulatory and customer requirements. You will enforce quality systems on the production floor, maintain compliance with ISO 13485...Medical device
- ...of innovation and supply in global health. With over 2000 employees... ...testing and point-of-care medical device solutions used in the... ...ensuring operational excellence, regulatory compliance, and seamless cross... .... Collaborative leader with excellent team-building...Medical device
Cordx Inc
Alpharetta, GA12 days ago - ...based product development leader supporting Mölnlycke's... ...a new chapter for our global Wound Care organization... ..., Marketing, Clinical, Regulatory, Quality, and... ...and work-life harmony: Medical, dental, and vision plans... ...management skills Medical device, healthcare, wound care...Medical deviceWorldwideFlexible hours
- ...Automation, Coatings, and Transmission & Distribution, providing global solutions for electric motors, variable frequency drives, soft... .... About The Role WEG Electric Corp. is seeking an experienced Principal Engineer to provide technical leadership for complex industrial...PrincipalFull timeWork at officeWorldwideMonday to Friday
WEG Electric Corp. (USA)
Duluth, GA2 days ago - ...Function of Position: The Global Customer Service Product Owner... ...platform sustainability and regulatory requirements. Process... ...training teams and business leaders to support successful adoption... ...working in a regulated industry; medical device experience is preferred....Medical deviceFull timeLocal areaRemote workFlexible hours
- ...Overview As a Principal Analog Design Engineer , you will lead the architecture, design, and verification of CMOS analog blocks for custom... ...by developing innovative products and solutions to meet our global customers' evolving needs and help make people’s lives easier,...PrincipalWork at officeLocal areaRemote workFlexible hours2 days per week
Renesas
Duluth, GA2 days ago - ...Job Description Job Description Senior Manager, Global Dangerous Goods Compliance Location: Alpharetta, GA (Hybrid) Position... ...Goods Compliance to join our Corporate Compliance and Regulatory Affairs team. Reporting to the Sr. Director of Compliance and Regulatory...
Arclin USA LLC
Alpharetta, GA8 days ago - ...and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research... ...staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing...Medical deviceContract workWorldwideNight shift
HonorVet Technologies
Alpharetta, GA3 days ago - ...Job Description Job Description Regulatory Affairs Specialist Job Summary We are seeking a detail-oriented Regulatory Affairs Specialist... ...within the healthcare, pharmaceutical, biotechnology, or medical device industry. The ideal candidate will have strong knowledge of...Medical device
Ova Technologies
Alpharetta, GA4 days ago - ...Associate Agreements. Research. Stay updated on changes in the medical device industry affecting customer contracts. Provide... ...stakeholders, like Business Development, Product Marketing, Legal, Regulatory Affairs, Service Department, Field Service, Manufacturing, and...Medical deviceContract workLocal area
Intuitive
Peachtree Corners, GA1 day ago - ...DayJob Title: Product Manager - Healthcare Medical Devices (Cardiovascular & Structural Heart)... ...About Us DuPont Healthcare is a global leader in advanced materials and innovative solutions... ...closely with Sales, R&D, Quality, Regulatory, Operations, and Marketing to ensure alignment...Medical deviceShift work
- ...of innovation and supply in global health. With over 2,100 employees... ...testing and point-of-care medical device solutions used in the... ...quality management systems, regulatory compliance, and team leadership... ...production, and regulatory affairs teams to ensure new products...Medical device
CorDx
Chamblee, GA3 days ago - ...trusted advisor for many industry-leading global enterprises, offering the most comprehensive... ..., configuration, and kitting of medical devices (mobile phones, tablets, and related equipment) meet all applicable regulatory, quality, and customer requirements. This...Medical device
Stratix
Peachtree Corners, GA2 days ago $85k - $140k
...across EMC, RF/Wireless, Product Safety, Cybersecurity, and Global Market Access. This role is ideal for a results-driven... ...capabilities. Preferred Qualifications Experience with medical device regulatory requirements, including FDA and EU MDR frameworks. Knowledge...Medical deviceFull timeFlexible hoursTUV SUD AMERICA, INC.
Alpharetta, GA1 day ago
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
- team leader mental health Norcross, GA
- office team lead Norcross, GA
- team leader Norcross, GA
- recruitment team leader Norcross, GA
- helpdesk team lead Norcross, GA
- compliance team leader Norcross, GA
- team lead Norcross, GA
- quality control team lead Norcross, GA
- disability team leader Norcross, GA