Sr. Regulatory Affairs Specialist - Global Medical Devices
West Pharmaceutical Services
West Pharmaceutical Services in Exton, PA is seeking a Senior Specialist, Regulatory Affairs to lead regulatory strategy for medical devices and combination products, ensuring submissions meet US and global requirements and maintaining compliance across lifecycle. This hybrid role requires onsite presence at least 3 days per week; no relocation. You will prepare and review submissions (510(k), IND/CTA, NDA/BLA/MAA), guide cross-functional teams, and maintain proficiency with eCTD, MasterControl, #J-18808-Ljbffr West Pharmaceutical Services
- West Pharmaceutical Services, Inc. seeks a Senior Regulatory Affairs Specialist to drive regulatory plans for medical devices and combination products. You will prepare global submissions, guide teams, and coordinate with agencies to ensure timely approvals. This hybrid...Medical device
- ...Senior Regulatory Affairs Specialist Integrated Resources, Inc is a premier staffing firm recognized... ..., providing updates to FDA and global regulatory agencies, processing and... ...minimum of 4+ years of experience in a medical device and/or pharmaceutical industry, and...SeniorMedical device
- West Pharmaceutical Services, Inc. is seeking a Senior Specialist, Regulatory Affairs to influence regulatory processes, author submissions, and support global registrations including US FDA and EU MDR. The role includes mentoring teammates and ensuring regulatory compliance...SeniorMedical deviceRelocation3 days per week
- ...including parenteral packaging, device, and contract manufacturing... ...-quality execution of all regulatory deliverables and ensures compliance... ...compliance to applicable global product and/or packaging regulatory... ...of global pharmaceutical, medical device, and related...SeniorMedical deviceContract workRelocation3 days per week
$130k - $209k
Job TitleSr Global Product Manager, MCT Clinical SystemsJob DescriptionSr Global Product... ...value based on market trends and regulatory requirements. Continuously optimize strategy... ...of experience in product management. Medical Device experience is required.Your skills include...SeniorMedical deviceFull timeWork experience placementWork at officeLocal areaImmediate startWork visaRelocation package3 days per week- ...sustainability efforts. Job SummaryThe Regulatory Affairs Sr. Specialist is responsible for influencing... ...authoring, reviewing, and supporting global registrations, including Premarket... ...ResponsibilitiesDevelop and implement medical device regulatory strategies for West’s...SeniorMedical deviceTemporary work
- ...- Knowledge of basic medical terminology - Proficiency... ...Continuous learner - Global mindset -... ...supporting Post Market Regulatory Affairs activities associated... ...metrics. The Regulatory Specialist is responsible for oversight... ...associated Medical Device Report and/or...Medical deviceWork experience placement
- ...for aligning working processes for TCS globally through a dotted line relationship with... ...and technical matters with focus on pre-regulatory approval activities.Establish... ...of experience in the pharmaceutical or medical devices industries.Customer-facing experience through...SeniorMedical device
- ...sustainability efforts. Job SummaryThe Senior Specialist, Regulatory Project Management is responsible... ...project execution for West’s global portfolio of medical devices, combination products, software-... ...partners with the Regulatory Affairs Lead, Cross-functional SMEs, and...SeniorMedical deviceContract workTemporary workWork at office3 days per week
- ...00Reference26-01017Remote50% Remote Job Description: Prepare regulatory documentation to support the market distribution of new and modified medical devices (510(k)/NTF) in US, Canada, and EU. Support global registrations in rest of world. Review device Labeling, including...Medical deviceLocal areaRemote work
- ...responsible for co-ordination of global regulatory submissions for in vitro diagnostic devices. Responsibilities will include:... ...of best practices for Regulatory Affairs processes Qualifications •... ...technical field • At least 2 years of medical device, diagnostic or related...Medical device
- ...remote), the Manager Product Supply Planning has the end-to-end accountability, executing the short to long-term planning horizon for global supply of a set of products across a global network of manufacturing sites to ensure excellent customer service. This role is the...Medical deviceTemporary workWork at officeRemote work
$105k - $169k
...Manager, Sustaining HardwareAs our Global Product Manager for... ...management of the MCT and Holter devices. These mature products remain... ...you will translate quality, regulatory, customer, service, supply, and... ...for regulated hardware or medical devices, required. You have experience...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...Marketing - Drug Delivery Devices (DDD) is responsible... .... This role leads global go‑to‑market strategy... ...evolving customer needs, regulatory considerations, and West... ..., R&D, Scientific Affairs, Scientific Communications... ...perferably within medical device, combination products...SeniorMedical deviceWork experience placementWork at office
- ...support the delivery of contract regulatory services. You will ensure... ..., and aligned with evolving global regulatory expectations and... ...closely with Regulatory Affairs, Quality Assurance, Commercial... ...listening skills.Experience in medical device regulatory affairs and/or...SeniorMedical deviceContract workLocal area3 days per week
$260k - $300k
...speed of life.As a global leader in clinical diagnostics... ...Senior Director, Medical & Scientific Affairs - Specialty Testing... ..., a team of medical specialists dedicated to all... ...development, regulatory submissions, and marketing... ...technology, medical device, or pharmaceutical industry...SeniorMedical deviceFull timeRemote workWork from homeFlexible hours- ...sustainability efforts. Job SummaryThe Sr. Counsel, Compliance Regulatory and Quality role is a... ...leadership across the Company’s global Compliance, Regulatory Affairs and Quality Assurance... ...experience working in pharmaceutical, medical device, biotech or manufacturing...SeniorMedical deviceWork at officeFlexible hours
- ...to business needs, role expectations, regulatory requirements, and West standards.This role... ...needs.Coordinate with local and global Learning & Development colleagues to support... ..., quality, healthcare, pharmaceutical, medical device, or regulated environment.Experience applying...SeniorMedical deviceWork at officeLocal area3 days per week
- ...reports, as required. Data Quality and Regulatory Analysis Review analytical release... ...Meetings), NDA, SNDA, MAA and other global regulatory submissions. Work with Quality... ...within the pharmaceutical and/or medical device industries, combination products, peptides...SeniorMedical deviceFull timeContract workWork at office
$22 - $25 per hour
...Benefits: Health and Wellness: Medical, Dental, Vision, and Wellness programs... ...to go further in your career. Join our global team of 14,000+ associates whose passion... ...daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice...SeniorMedical deviceHourly payFor contractorsLocal areaMonday to FridayFlexible hoursShift work- West Pharmaceutical Services in Exton, PA seeks a Principal Specialist, Regulatory Affairs (Medical Devices) to influence regulatory strategies and oversee global submissions, including US FDA 510(k) and EU MDR documentation for new products and changes. The role partners...Medical device
- AGC Chemicals Americas (AGCCA) in Exton, PA, is seeking a Product Stewardship and Regulatory Affairs Specialist to support compliance across the Americas. The role interacts with R&D, manufacturing, and legal to enable sales of new and existing products. The candidate will...Work at office
- West Pharmaceutical Services, Inc. is seeking a Principal, Regulatory Affairs - Intelligence, Pharmaceutical in Exton, PA. This role requires deep expertise in global regulatory frameworks with a focus on containment systems and drug products, translating intelligence into...
- ...background in HR generalist practices, solid understanding of global workforce regulations, and expertise in talent management, this... ...Knowledge, Skills And Abilities Experience in Pharmaceutical, Medical Device or Manufacturing industries preferred. High level of...SeniorMedical deviceWork experience placementWork at officeLocal area3 days per week
- ...through our sustainability efforts. Job SummaryThe Senior Director, Global Logistics, Warehousing & Distribution is an enterprise-level... ...customs regulationsMaintain inspection readiness for global regulatory audits.Ensure traceability and product integrity across distribution...SeniorWork at officeLocal area
$85k
...Senior Buyer / Senior Procurement Buyer King of Prussia, PA · Full-time Own supply continuity and supplier strategy for a medical device company, partnering across Planning, Quality, and Operations to keep production on track. This is a high visibility role with...SeniorMedical deviceFull timeContract work- ...businesses from the earliest stages of innovation to their emergence as global market leaders. In addition, Applied Energy Systems is ISO certified providing precision welding services to the medical device industry and is a sales representative to a leading manufacturer of...Medical deviceRelocation package
- ...Pharmaceutical Services, Inc. is seeking a Senior Specialist, Regulatory Operations to publish, format, and maintain regulatory documentation for global product portfolios. You will work... ...improvement within Regulatory Affairs, with hybrid onsite work requirements....Senior
- ...organization. In a hybrid environment, you will guide talent acquisition, compensation, and learning initiatives, while ensuring regulatory compliance and a strong employee relations program. Ten-plus years in HR in global settings are expected. #J-18808-Ljbffr RXinsiderSenior
- West Pharmaceutical Services, Inc seeks a Senior Counsel, Compliance, Regulatory & Quality in Exton, PA. This strategic role offers integrated legal leadership across global Compliance, Regulatory Affairs and Quality Assurance functions. The incumbent will ensure...Senior
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