Senior Regulatory Operations Lead, Global Labeling & UDI
Hologic
Hologic, Inc. is seeking a Senior Manager, Regulatory Operations to lead strategic and operational regulatory activities across global markets. This role oversees labeling, post-market reporting, UDI governance, and regulatory database management, ensuring compliant and scalable processes while supporting a growing medical device portfolio. The incumbent directs the regulatory team, collaborates with R&D, Quality, Clinical and Manufacturing, and translates regulations into practical plans, #J-18808-Ljbffr Hologic
- ...Analyst to advance product quality and patient safety across the global organization. You will lead complaint handling and regulatory reporting, drive cross-functional initiatives, and partner with senior leadership to implement data-driven improvements. The role requires...SeniorRegulatory
- ...ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit... ...documents, creating product labeling, defining user-validation activities, redeveloping regulatory claims, surgical technique... ...and sales teamsDetermining and leading market research to identify market...SeniorRegulatoryHourly payTemporary workWork at officeLocal areaShift work3 days per week
$186.95k - $286.73k
...Olympus: .Job DescriptionThe Sr Director, Global Head of Clinical Operations reports directly to the Global Head... ...project deliverables are received.Leads strategic and operating planning... ...Assurance to prepare for and support regulatory agency inspections and sponsor audits...SeniorRegulatoryFull timeContract workLocal areaWorldwideAfternoon shiftEarly shift- Job Summary The Senior Manager, Regulatory Operations provides strategic and operational... ...areas including labeling, post-market regulatory... ...Identification (UDI) governance. This role ensures global compliance with regulatory... ...updates, and changes. Lead regulatory post-market...SeniorRegulatoryImmediate start
$204.5k - $306.73k
Job SummaryInsulet’s Global Operations team is seeking a Senior Director, Digital Transformation, to lead enterprise-wide transformation initiatives that deliver measurable... ...medical device manufacturing processes and regulatory requirements. Strong knowledge of process...SeniorRegulatoryFull timeWork at officeFlexible hours- ...Description Job Description HIGH-LEVEL OVERVIEW The Senior Global Trade Compliance Analyst is a subject matter expert who... ...report on export compliance metrics and trends · Monitor regulatory changes and lead targeted process improvements ESSENTIALS · 7+...SeniorRegulatoryRelocation package
$185.67k - $204.5k
..., one of Danaher’s 15+ operating companies, our work saves... ...possible.The Senior Counsel is responsible for providing global legal support across the... ...government investigations, and regulatory matters, partnering... ...diagnostics compliance (e.g., labeling, promotional review,...SeniorRegulatoryFull timeContract workWork at officeRemote workWork from homeFlexible hours$106.8k
...Diversity - Innovation - Caring - Global Collaboration - Winning Spirit... ...documents, creating product labeling, defining user-validation activities, redeveloping regulatory claims, surgical technique... ...sales teams Determining and leading market research to identify market...SeniorRegulatoryHourly payTemporary workWork at officeLocal areaShift work3 days per week$88.74k - $110.93k
...Sr. Regulatory Specialist The role will be reporting to the Senior Manager of Regulatory & Clinical Affairs... ...development and revision of labeling, advertising and... ...registrations in different global regions. Compile... ...of Troy Standard Operating Procedures. Serve as...SeniorRegulatoryFull timeTemporary workFixed term contractWork at officeWorldwide- ...GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt... ...hire an enthusiastic individual for a Senior Regulatory Affairs Specialist position (hybrid... ...of test protocols and reports Assesses labeling materials, including Instructions for...SeniorRegulatoryHourly payWork at officeLocal areaRelocationShift work3 days per week
- ...outside of the US. Responsibilities: Prepare and submit global regulatory applications, in countries such as Japan, India, China,... ...and annual reports) and EU MDR Submissions. Review device labeling (including IFU) and advertising materials for compliance with...SeniorRegulatory
$110k - $160k
Senior Manager, Quality Systems (Global Process Owner) Reporting to the head of Global Quality... ..., and aligned with both regulatory requirements and business... ...digital enablement, and operational excellence across Quest’s... ...proactive compliance. Lead change management efforts...SeniorRegulatoryTemporary workWork experience placementWork at officeLocal areaWork from homeFlexible hours- ...mentor junior team members, ensuring high-quality service and regulatory compliance. The role is full-time, based in Framingham, with... ...advance within a collaborative, client-centered firm. Strong operational and CRM skills are essential. #J-18808-Ljbffr Bartholomew &...SeniorRegulatoryFull time
$89.2k
...Diversity - Innovation - Caring - Global Collaboration - Winning... ...business provides proven, leading solutions to treat several common... ...procedures. As a Senior Regulatory Affairs Specialist , you will... ...submissions. • Review device labeling and advertising materials...SeniorRegulatoryHourly payWork at officeLocal areaShift work3 days per week$88.74k - $110.93k
...talent! Position: Sr. Regulatory Specialist... ...will be reporting to the Senior Manager of Regulatory... ...development and revision of labeling, advertising and promotional... ...in different global regions. Compile and... ...Helen of Troy Standard Operating Procedures. Serve as...SeniorRegulatoryFull timeTemporary workFixed term contractWork at officeLocal areaRemote workWorldwideMonday to FridayFlexible hours- ...Boston Scientific is seeking a Senior Regulatory Affairs Specialist to provide regulatory support for development, sustaining engineering,... ...activities. You will develop regulatory strategies, prepare global submissions, and partner with cross-functional teams to ensure...SeniorRegulatoryWork at office3 days per week
- Boston Scientific is seeking a Clinical Trial Operations Specialist II to support global clinical studies within Urology, coordinating across neuromodulation... ...teams to plan, execute, and oversee trials, ensure regulatory compliance, and drive high-quality study conduct,...Regulatory
- ...HillsDiversity - Innovation - Caring - Global Collaboration - Winning... ...development, manufacturing, regulatory compliance and... ...regulatory, supplier, customer and operational data are standardized, accurate... ...with FDA, MDR/IVDR, ISO 13485, UDI, GUDID, EUDAMED and other applicable...SeniorRegulatoryHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week
- Boston Scientific is seeking a Senior Regulatory Affairs Specialist to provide regulatory support for product development, sustaining engineering... ...role emphasizes developing regulatory strategies, preparing global submissions, and mentoring regulatory affairs colleagues in a...SeniorRegulatory
- ...Scientific is seeking a Principal Product Analyst to advance product quality and patient safety across our global organization. You’ll lead complaint handling and regulatory reporting activities and drive cross-functional initiatives that strengthen our post-market quality...SeniorRegulatory
- ...Innovation - Caring - Global Collaboration - Winning... ...digital solutions. As the Senior Program Manager, AI... ...and Enablement, you will lead and accelerate MedTech... ...adoption.Establish program operating cadence and governance:... ...environments: Embed regulatory, patient safety, privacy...SeniorRegulatoryHourly payWork at officeLocal areaShift work3 days per week
$135k - $145k
..., one of Danaher’s 15+ operating companies, our work saves... ...possible.The Senior Manager, Digital Content... ...compliance with legal and regulatory standards across all digital... ...traffic, and support lead generation.Collaborate... ...strategy through execution.Global & Matrixed Environment...SeniorRegulatoryFull time- ...Regulatory Affairs Specialist Location: Marlborough, Massachusetts... ...and the implementation of labeling for Medical Device UDI project? Do you want to... ...corporate SOPs (Standard Operating Procedures) for Labeling,... ...internal and key external global regulatory requirements...Regulatory
- IPG Photonics is seeking a Senior Internal Audit Manager to lead the global internal audit function across operations, finance, compliance, and risk management. The role partners with Finance, IT, Operations, Manufacturing, Supply Chain, HR and leadership to strengthen...Senior
$85.6k - $109.2k
...Whether you’re working in our four global Home Offices, Distribution... ...Fortune 100 company and the world’s leading off-price retailer. Job Description: Senior Audit Specialist Job Summary: The... ...ensure compliance with U.S. Customs, regulatory requirements, industry standards,...SeniorRegulatoryTemporary workWork experience placementWork at officeLocal areaHome office$110k - $160k
A leading diagnostics company in Massachusetts seeks a Senior Manager, Quality Systems to oversee global process design and compliance. The role involves developing global policies aligned with regulatory standards and driving process maturity. Candidates should have over...Regulatory- ...HillsDiversity - Innovation - Caring - Global Collaboration - Winning Spirit... ...is seeking a Global Regulatory Compliance Director, Internal... ...responsibilities will include:Lead, coach, and develop a global team... ...influencing global teams and senior stakeholdersAbility to travel...RegulatoryHourly payWork at officeLocal areaShift work3 days per week
$85.6k - $109.2k
...Whether you’re working in our four global Home Offices, Distribution... ...100 company and the world’s leading off-price retailer. Job... ...The Growth Of Your Career The Senior AI Analyst sits within the enterprise... ...management, and other regulatory requirements. The Senior AI Analyst...SeniorRegulatoryTemporary workWork at officeLocal areaHome office2 days per week- Boston Scientific is seeking a Global Regulatory Compliance Director, Internal Audit for its Global Quality Systems group. The role provides strategic leadership of the GRC internal audit program across the global network, partnering with site, divisional, regional, and...Regulatory
- Digital Federal Credit Union is seeking a senior transformation lead to drive cross-enterprise simplification across journeys, platforms, and functions... ...leaders without authority, define metrics, and ensure regulatory considerations while delivering durable improvements in...SeniorRegulatory
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