Global Regulatory Affairs Specialist - Medical Devices (Hybrid)
RXinsider LTD.
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 role requires strong leadership and regulatory know-how relevant to scope of products. The role emphasizes MDR/FDAs, lifecycle management, and post-market support. #J-18808-Ljbffr RXinsider LTD.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Specialist - Medical Devices (Hybrid) in Exton, PA vacancy
- ...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...Medical deviceRelocation3 days per week
- ...Pharmaceutical Services, Inc. in Exton, PA is seeking a Manager of Global Supply Planning, Medical Device, to oversee end-to-end planning across a global... ...service levels and supply feasibility. The position is hybrid (3 days in office/2 days remote). A Bachelor's degree is...Medical deviceWork at officeRemote work
- This is a hybrid position requiring the team member to... ...parenteral packaging, device, and contract manufacturing... ...execution of all regulatory deliverables and ensures... ...compliance to applicable global product and/or... ...global pharmaceutical, medical device, and related environmental...Medical deviceContract workRelocation3 days per week
- ...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... ...across programs. The position is hybrid, requiring onsite presence at least 3...Medical deviceRelocation3 days per week
- ...- 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
- This is a hybrid position requiring the team member to be... ...efforts. Job SummaryThe Regulatory Affairs Sr. Specialist is responsible for influencing... ..., and supporting global registrations, including... ...ResponsibilitiesDevelop and implement medical device regulatory strategies for...Medical deviceTemporary work
- ...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...Medical device
Integrated Resources
West Chester, PA2 days ago - West Pharmaceutical Services is seeking a Manager, Product Supply Planning for a hybrid role (3 days in office/2 days remote). You will own end-to-end global supply planning for a portfolio of products, ensuring high service levels and efficient inventory across a network...Medical deviceWork at officeRemote work
- ...and planet through our sustainability efforts. JOB SUMMARYIn this hybrid position (3 days in office/2 days remote), the Manager Product... ...accountability, executing the short to long-term planning horizon for global supply of a set of products across a global network of...Medical deviceTemporary workWork at officeRemote work
- ...Services, Inc. is seeking a Senior Specialist, Regulatory Operations to publish, format, and maintain... ...regulatory documentation for global product portfolios. You will work independently... ...improvement within Regulatory Affairs, with hybrid onsite work requirements. #J-18808-...
- ...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
Integrated Resources
Wayne, PA1 day ago $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$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...Medical deviceFull timeWork experience placementWork at officeLocal areaImmediate startWork visaRelocation package3 days per week- ...Overview Leader of Healing Strategies - a medical sales and distribution company. Future RN... ...practice. Role Description This is a hybrid role for a 1099 Independent Medical Sales... ...Experience in the healthcare or medical device industry is an advantage Support Healing...Medical deviceContract work
Healing Strategies
Malvern, PA3 days ago - 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
- This is a hybrid position requiring the team member... ...delivery of contract regulatory services. You will ensure... ...aligned with evolving global regulatory... ...closely with Regulatory Affairs, Quality Assurance, Commercial... ...skills.Experience in medical device regulatory affairs and...Medical deviceContract workLocal area3 days per week
- This hybrid position is located in Exton, PA and open for relocation... ...comply with applicable regulatory requirements, industry standards... ...policies. Also, oversee the Global QMS, as the overall Lab QMS... ..., biotechnology, medical device, contract testing, or life sciences...Medical deviceContract workWork at officeRelocationRelocation package
- ...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
Applied Energy Systems, Inc.
Malvern, PA4 days ago - ...aligning working processes for TCS globally through a dotted line... ...technical matters with focus on pre-regulatory approval activities.... ...experience in the pharmaceutical or medical devices industries.Customer-facing... ...time.What We OfferThis is a hybrid position requiring the team...Medical device
- ...Sr. Counsel, Compliance Regulatory and Quality role is a strategic... ...across the Company’s global Compliance, Regulatory Affairs and Quality Assurance... ...in pharmaceutical, medical device, biotech or manufacturing... ...problemsWhat We OfferThis is a hybrid position requiring the...Medical deviceWork at officeFlexible hours
- This is a hybrid position requiring the team member to be onsite... ...needs, role expectations, regulatory requirements, and West standards... ....Coordinate with local and global Learning & Development... ...healthcare, pharmaceutical, medical device, or regulated environment.Experience...Medical deviceWork at officeLocal area3 days per week
- This is an hybrid position requiring the team member to be onsite... .... Job SummaryThe Manager, Regulatory Affairs Digital Health & Innovation... ...for software-enabled medical devices, including Software in a Medical... ...requirements, and related global expectations Experience...Medical device3 days per week
- This is a hybrid position requiring the team member to... .... Job SummaryThe Senior Specialist, Regulatory Project Management is responsible... ...execution for West’s global portfolio of medical devices, combination products,... ...with the Regulatory Affairs Lead, Cross-functional SMEs...Medical deviceContract workTemporary workWork at office3 days per week
- ...responsible for leading the global strategy, governance, architecture... ..., security governance, regulatory compliance, cyber resilience... ...industries such as Medical Devices, Pharmaceutical or Life Sciences... ...time.What We OfferThis is a hybrid position requiring the team...Medical deviceLocal areaRemote workRelocation
- This is a hybrid position requiring the team member to be onsite... .... Job SummaryThe Principal Regulatory Affairs Project Manager is... ...across West’s portfolio of medical devices, combination products, and... ...execution, and compliance across global markets. In this role, you...Medical deviceTemporary workRelocationVisa sponsorshipFlexible hours3 days per week
- ...out of our Exton, PA office (Hybrid). This is an excellent opportunity... ...experts within a leading global consulting company.This role... ...remaining actively involved in regulatory compliance, auditing,... ...Participation in an OSHA-mandated medical surveillance program will be...Work at officeLocal areaFlexible hours
- ...and optimizing the company’s global ERP platforms, software... ...scalable growth, cybersecurity, regulatory compliance, and data-driven... ...industries such as pharmaceuticals, medical devices, life sciences, or highly... ...time.What We OfferThis is a hybrid position requiring the team...Medical deviceRelocationFlexible hours
- ...development and maintenance of a portfolio of global security and fraud policies and... ...Security and Fraud teams to understand global regulatory requirements, develop global and... ...best.How We WorkVanguard has implemented a hybrid working model for the majority of our crew...Full timeWork experience placement
$88k - $96k
...process. Product Stewardship and Regulatory Affairs Sp Active Full-Time Exton,... ...Americas (AGCCA) is a global subsidiary of AGC Inc., a multinational... ...and regulatory affairs specialist will support the Company’s... ..., lactation, and related medical conditions), national origin...Full timeWork at officeWorldwideOverseas
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Affairs Specialist - Medical Devices (Hybrid). Be the first to apply!
