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
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Sr. Regulatory Affairs Specialist - Global Medical Devices in Exton, PA vacancy
- ...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
Integrated Resources
West Chester, PA1 day ago - ...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- West Pharmaceutical Services, Inc. seeks a Senior Specialist, Regulatory Affairs for Medical Devices. The role develops regulatory strategies and oversees global submissions, including US/EU/China, with emphasis on timely, compliant registrations. Collaboration with cross...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
- ...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
$157.2k - $225k
Senior Director, Global Quality & Regulatory Location: Exton, PA/USA We’re building our Biomedical Quality... ...regulatory requirements governing medical devices, biomaterials, and related products.... ...Quality Assurance and/or Regulatory Affairs, preferably within medical device...SeniorMedical device- ...- 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
- ...Senior Specialist, Regulatory Affairs This is a hybrid position requiring... ...opportunity. The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing... ..., and supporting global registrations,... ...and implement medical device regulatory strategies...SeniorMedical deviceTemporary workWork experience placementWork at officeRelocationFlexible hours3 days per week
- ...requirements * Complementary systems, such as devices, safety administration systems, etc. *... ....Work closely with all other members of Global Technical Customer Support team to assure... ...years Of experience in pharmaceutical or medical device industry required and Experience...SeniorMedical device
- ...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
- ...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 at office
- ...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
- West 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 manufacturing network. The role requires strong leadership and collaboration with Commercial, Product Management...Medical deviceWork at officeRemote work
- ...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 of facilities. You...Medical deviceWork at officeRemote work
- ...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
- ...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
- ...background in HR generalist practices, solid understanding of global workforce regulations, and expertise in talent management, this... ...Knowledge, Skills and AbilitiesExperience in Pharmaceutical, Medical Device or Manufacturing industries preferred.High level of interpersonal...SeniorMedical deviceWork at officeLocal 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
- ...Engineering, Source, Deliver, IT, Quality, Regulatory, and External Manufacturing to... ....A minimum of 8 years of experience in medical device, pharmaceutical, healthcare, or another... ...equivalent) is preferredExperience working in global, cross-cultural, and virtual teams is...SeniorMedical deviceFull timeContract workLocal areaImmediate start
- ...Services, Inc. is seeking an international tax professional to manage U.S. tax compliance and reporting. The role offers exposure to global tax operations and the chance to influence process modernization in a collaborative hybrid work environment. Ideal candidates will...Senior
$115k - $125k
...Supplier Quality EngineerThe Sr. Supplier Quality Engineer will... ..., 21CFR part 820 and current regulatory standards.We Bring:A... ...Management at a FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or... ...we go beyond them. Join our global team powered by science, creativity...SeniorMedical deviceHourly payDérivés Résiniques et Terpéniques
Exton, PA1 day ago$90k - $120k
...8 years of facility engineering experience or similar role in medical device or related industry.Experience with AutoCAD.Knowledge of building... ...we don't just meet expectations – we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to...SeniorMedical deviceHourly payFor contractorsLocal areaDérivés Résiniques et Terpéniques
Exton, PA1 day ago$22 - $25 per hour
...range: $22.00 - $25.00 Health and Wellness: Medical, Dental, Vision, and Wellness programs... ...Dare to go further in your career. Join our global team of 14,000+ associates whose passion... ...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 workAvantor
King of Prussia, PA1 day ago- ...high power electronics, electro-mechanical devices, firmware development, and EMC testing... ...experience in electrical design within the medical device, aerospace, or other regulated... ...2026. About Actalent Actalent is a global leader in engineering and sciences services...SeniorMedical deviceContract workTemporary work
Actalent
Malvern, PA7 days ago - ...Services, Inc in Exton, PA, is seeking a Principal Regulatory Affairs Project Manager for medical devices to lead complex, high-visibility regulatory programs... ...regulatory strategies, timelines and compliance in global markets, collaborating with R&D, quality, clinical affairs...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
- AGC Chemicals Americas is seeking a Product Stewardship and Regulatory Affairs Specialist to support compliance across the Americas from Exton, PA. You will manage product stewardship activities to enable sales of new products and maintain the right to operate with current...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Sr. Regulatory Affairs Specialist - Global Medical Devices. Be the first to apply!
Related searches
- research compliance officer Exton, PA
- regulatory compliance associate Exton, PA
- regulatory officer Exton, PA
- healthcare compliance officer Exton, PA
- medicare compliance specialist Exton, PA
- regulatory affairs specialist Exton, PA
- compliance specialist Exton, PA
- compliance consultant Exton, PA
- coding compliance specialist Exton, PA
- aml compliance analyst Exton, PA