US Regulatory Strategy Lead — Medical Devices & IVDs
R&D Partners
R&D Partners is seeking a Regulatory Affairs Senior Specialist to lead strategic regulatory delivery for the US market across medical technology and devices. You will drive FDA submissions, registrations and lifecycle management while partnering with Commercial, Product and Quality teams. The role requires 3+ years in Regulatory Affairs with deep knowledge of FDA requirements and a hands-on approach to risk management, regulatory intelligence, and continuous process improvement. #J-18808-Ljbffr R&D Partners
- AbbVie in Cambridge, MA seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins to develop and implement regulatory strategies for on-market and development-stage products. You will coordinate data gathering for filings, responses...Regulatory
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- ...health issues today and address the medical challenges of tomorrow. We strive... ...information about AbbVie, please visit us at Follow @abbvie on LinkedIn,... ...Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is responsible...RegulatoryLocal area
$185k - $210k
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...life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at... ...shape the future of fabrication, come build it with us.Your Impact:As the Fulfillment Strategy & Network Lead, you will be the "right hand" to our fulfillment...Medical deviceFull timeWork at officeWorldwideFlexible hoursShift work$163.4k - $322.1k
...The Experience Design Strategy Manager is a client-facing... ...be responsible for: Leading engagements that... ...evolving customer and regulatory landscape, mounting pipeline... ...global big pharma to medical device companies, to drive... ...of experience in the US Life Sciences ecosystem...RegulatoryMedical deviceLocal areaFlexible hours$198.7k - $391.6k
...The Experience Design Strategy Senior Manager is a client... ...executive level and leading cross-functional teams... ...evolving customer and regulatory landscape, mounting... ...global big pharma to medical device companies—to drive business... .... #Customer_US #CSD_US Deloitte...RegulatoryMedical deviceLocal area$202.4k - $265.7k
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Job title: Lead, US Public Affairs & Patient Advocacy Rare DiseasesLocation... ...into Sanofi's rare disease strategy.Reports To: Head, US Public... ...including Corporate Affairs, Medical Affairs, Commercial, and R&D... ...including Medical Affairs, Regulatory Affairs, Market Access,...RegulatoryFull timeRemote work$154.4k - $242.55k
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$178.5k - $257.83k
Job Title: Lead, US Hematology Pipeline CommercializationLocation:... ...for shaping the US commercial strategy, market development approach,... ...trusted partner across US, Global, Medical, R&D, Market Access, and the... ...relationship among clinical, regulatory, medical, access, and...RegulatoryFull time- ...Director, AS&T Projects & Strategy, you will play a key... ...with functions such as Regulatory Affairs, CMC, and Quality... ...of relevant US and EU regulatory frameworks... ...limited to: ~ Medical, Dental and Vision Insurance... ...biologics, and medical devices. In the coming years,...RegulatoryMedical deviceHourly pay
$110k - $126.5k
...River Associates is a leading global consulting firm... ...pertaining to litigation and regulatory proceedings, and... ...critical business strategy and performance-related... ...biotechnology, diagnostics, and medical device companies achieve... ...team, you will help us deliver high-impact...RegulatoryMedical deviceWork at officeWork from home3 days per week$135k - $225k
Job Family:Strategy & Transformation ConsultingTravel... ...healthier lives, while medical devices enable patients to... ...commercialization, and regulatory and compliance solutions... ...Conjoint, etc.)Designing and leading primary interviews... ...fee.SummaryLocation: US - Remote (Any location...RegulatoryMedical deviceFull timeWork experience placementWork at officeImmediate startRemote workFlexible hours$155k - $214k
...About This Role The US Lifecycle Management Lead is a senior individual contributor accountable... ...by robust supply, quality, regulatory, and flow‑of‑goods strategies. You will partner closely with Asset... ..., but not limited to: ~ Medical, Dental, Vision, & Life insurances...RegulatoryFull timeTemporary workLocal area- Biogen is seeking an Associate Director to provide regulatory strategic advice for U.S. communications including disease education, promotional materials, and medical communications. The role also reviews global materials to ensure competitiveness and compliance with FDA...Regulatory
$105k
...fully remote in the US preferably on EST... ...evaluation lead and participates within... ...clinical development strategy. ~ Writes... ...ready for various regulatory agency and external... ...to peer-reviewed medical journals. Works with... ...the Medical Device industry a plus....RegulatoryMedical deviceTemporary workFixed term contractWork at officeRemote workWorldwideFlexible hours- Sanofi US Services in Cambridge, MA seeks a Health Value Translation Lead within PDMD to represent the department at Global Project... ...Integrated Patient Disease Strategy across indications. You will... ...Advocacy Groups, and contribute to regulatory and payer submissions using...RegulatoryLocal area
$88.6k - $246.6k
The Solution Implementation Lead is the end‑to‑end execution... ...operationalization of new connected medical device and digital health solutions... ...line. The role bridges strategy, execution, validation, and... ..., operational workflows, regulatory considerations, and validation...RegulatoryMedical deviceFull timePart timeImmediate startRemote workWorldwide- ...Organization in Cambridge, MA is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to steer labeling strategy across US and EU. You will work with Clinical,... ...labeling for pharmaceutical drugs and devices and ensure alignment with Health Authority...Regulatory
- ...Sanofi is seeking a Medical Director, Dermatology for the US Immunology Medical Affairs team, based in Cambridge... ...executes an integrated US medical strategy for Dermatology products,... ...with Medical Field Team, Clinical, Regulatory, Market Access, and Commercial units...RegulatoryLocal area
$122.25k - $176.58k
...support for global promotional material regulatory review (30%) with transversal excellence... ...system - and innovative pipeline - enables us to invent medicines and vaccines that... ...enhanced through our diverse portfolio of medical device and diagnostic products. Together, we...RegulatoryMedical deviceFull timeWork at officeLocal areaWorldwide- Siemens Healthineers is seeking a Regulatory Affairs Professional in a hybrid role based in Walpole... ...ensure technical files and labeling meet US/EU requirements. The role requires a scientific degree, 2+ years in IVDs or medical devices, and strong document control and...RegulatoryMedical device
- ...seeking an Associate Director, Medical Strategy to develop and execute... ...Clinical Development, Commercial, Regulatory and Field Medical teams, and... ...and ISR programs. You will lead initiatives, ensure scientific... ...to advance oncology programs. #J-18808-Ljbffr Jobleads-USRegulatory
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$230.9k - $384.8k
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...and Mission - to be the leading provider of automation... ...This includes leading strategies and tactics related to... ...in pharmaceutical or medical device validation ~5+ years... ...industry guidance and regulatory requirements... ...entirety. For US geography, the salary...RegulatoryMedical deviceTemporary workFor contractorsWork experience placementWork at officeWeekend work- ...pharmaceutical, biotech, and medical device industries with our... ...trial data and regulatory submission challenges.... ...maintains an industry-leading customer satisfaction... ...employees can thrive. Join us at MMS and be part of... ...Evaluation and Mitigation Strategy (REMS) programs and...RegulatoryMedical deviceRemote jobH1bVisa sponsorship
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