Director, Regulatory Affairs - Compliance Systems & Labeling
$196.5k - $245.6kJacobs Management Group
Global Regulatory Strategy Leader
Step into a high-impact leadership role shaping global regulatory strategy for life-sustaining blood and cell technologies. My client is seeking a visionary regulatory leader to champion compliance systems, elevate global labeling strategy, and guide complex submissions that directly impact patients worldwide. This is your opportunity to influence executive decisions and drive a culture of quality across the full product lifecycle.
Why You Should Apply
- $196,500 – $245,600 base salary + 30% target bonus
- Executive-level visibility with influence across global business units
- Lead regulatory strategy for innovative medical device and combination products
- Hybrid onsite role in Lakewood, CO with global scope and 10–15% international travel
- Comprehensive medical, dental, vision, 401(k) match, wellness programs, and robust total rewards
What You'll Be Doing
- Direct global regulatory affairs and labeling strategy
- Oversee 510(k), PMA, IDE, CE Mark, NDA/ANDA and international submissions
- Serve as primary interface with global regulatory authorities
- Lead compliance programs including UDI and regulatory operations
- Partner cross-functionally with R&D, Clinical, Quality, Legal, Manufacturing, and Marketing
- Act as PRRC and champion a culture of quality and compliance
- Guide and develop a high-performing regulatory team
About You
- Be able to do the job as described.
- Deep experience with both sterile disposables and electro-mechanical devices with embedded software
- Proven success representing novel technologies to regulatory authorities and securing approvals
- Expertise across US, EU, and Canada regulatory frameworks
- Experience with drug/device combination products and PRRC responsibilities
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Director, Regulatory Affairs - Compliance Systems & Labeling in Denver, CO vacancy
$196.5k - $245.6k
...a difference. Join us and help shape wherever we go next. You create your future and ours. As Director of Regulatory Affairs - Compliance Systems and Labeling , you'll direct regulatory and labeling activities for Terumo Blood and Cell Technologies and collaborate...SuggestedCasual workWork at officeRelocationTerumo BCT
Lakewood, CO8 days ago$195k - $245k
...Director, Regulatory Affairs (Medical Devices) Medical Device | Global Scope |... ...global regulatory affairs and labeling strategy across a diverse... ...management, and global compliance initiatives. This is a... ...closely with Quality Management Systems. Regulatory...SuggestedFull timeLocal areaWorldwideSystem One
Denver, CO1 day ago- ...liver cell function and portal-systemic shunting, attributes of liver... ...execution of strategies for regulatory approvals to introduce new... ...stakeholders, including Medical Affairs, Quality, and Laboratory... ...review of promotional material, labeling content, product and process...Suggested
$120k - $150k
...Product Manager, Compliance Systems & Analytics - Denver (Hybrid) Western Union is seeking a strategic, data-driven, and execution-focused... .... Partner with Risk and Compliance teams to understand regulatory use cases, pain points, and future-state needs to pursue "...SuggestedFull timeTemporary workWork at officeWork from homeRelocationVisa sponsorshipWork visaFlexible hours3 days per weekWestern Union
Denver, CO1 day ago$110k - $150k
...end-to-end delivery of several complex compliance technology initiatives across the organization... ...scope and schedule. Translate regulatory and business objectives into program... ...decisions, and milestones. Anticipate systemic risks across the portfolio and...SuggestedFull timeTemporary workWork at officeVisa sponsorshipWork visaShift work3 days per weekWestern Union
Denver, CO2 days ago- ...Job Description Job Description As Director of Regulatory Affairs – Compliance Systems and Labeling, you’ll direct regulatory and labeling activities and collaborate with senior teams to define strategy and compliance programs. You’ll play an integral part in launching...
MRINetwork Jobs
Denver, CO28 days ago $190k
...functional and non-functional requirements for planning platforms Leading full lifecycle implementations for Advanced Planning Systems (APS) in Supply Chain Hands-on experience designing and deploying UI/UX and Kinaxis configuration to support one or more of the...Work at officeLocal areaBoston Consulting Group
Denver, CO6 days ago$160k - $200k
...development. Position Overview: The Senior Manager of Financial Systems, Planning & Reporting is responsible for building a high-... ...building financial systems at scaling companies. ~ Strong compliance, documentation discipline, and cross-functional coordination....Tract Capital
Denver, CO17 hours ago$230k - $265k
Danaher Corporation is seeking a Sr. Director, Health Systems Executive for Beckman Coulter Diagnostics, located in Denver, Colorado. In this role, you will build and execute strategic plans, coach a dynamic sales team, and directly impact company growth. Candidates must...Remote job$120k - $150k
Current Energy Group Manager/ Senior Manager (Power System Planning) Remote·Full time Company website Apply for Manager/ Senior Manager... ...client deliverables: reports, presentations, and formal regulatory filings. Assist with editing, formatting, proofreading, fact-checking...Full timeTemporary workRemote work- ...Job Summary: The Compliance Policy Manager will work collaboratively within the Compliance Department Team and with other teammates throughout... ...and trainings reflect accurate policy guidance. ct as system administrator for policy management system , PolicyHub ,...
Macpower Digital Assets Edge
Denver, CO17 hours ago - ...seeking an experienced and dynamic Director or Associate Director of Regulatory Affairs that will be responsible for... ...stakeholders to ensure regulatory compliance, provide consultation on regulatory... ...reduce costs for the healthcare system. Our team members work in a dynamic...Remote work
Padagis
Denver, CO17 hours ago - ...health organization in Colorado is seeking a Health Information Management (HIM) Manager to oversee daily operations and ensure compliance with regulations. The ideal candidate will have a strong background in health information management, leadership experience, and...
$102k - $112k
...independently manages SIU responses to regulatory exams, audits, and program-level information... ...submitting responses, and engaging with compliance, legal, and senior leadership as... ...compliance surveillance tools, investigative systems, and SIU resources, collaborating with Compliance...Work at officeRemote workTransamerica
Denver, CO4 days ago$187.52k - $234.4k
...individual for the position of Director, Regulatory Advertising & Promotion .... ...of the Global Regulatory Affairs (GRA) team based in the US.... ...for clinical trials, labeling, etc. Develop and maintain... ...and their Agencies, Legal, Compliance, and Medical Affairs. Provide...Work at officeWorldwideSumitomo Pharma
Denver, CO3 days ago- ...client is seeking a Senior Enterprise Resource Planning (ERP) Systems Programmer & Manager for an exciting contract to hire scenario.... ...environment, ensuring high-fidelity system integration. Reporting to the Director of Infrastructure Services, the role manages a specialized team...Contract workFor contractorsLocal area
$189.5k - $284.3k
...Job Primary purpose: The Director, NERC CIP Compliance is responsible for establishing and... ...through closure. Audit Readiness & Regulatory Interface: Prepare the organization... ...Security, Engineering, Information Systems, Computer Science, or a related...TallGrass
Denver, CO4 days ago$150k - $195k
...To manage and oversee air permitting and compliance activities of the Air Compliance Team in... .... Conduct State and Federal regulatory applicability analyses. Frequently... ...Foster a positive open work environment, systems approaches and disciplined execution of...Temporary workWork experience placementLocal areaImmediate startFlexible hoursNight shiftTallGrass
Denver, CO4 days ago- ...leading pharmaceutical company is seeking an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions... ...Affairs, particularly with ANDAs and FDA compliance. The position is available remotely for candidates...Remote work
Padagis
Denver, CO4 days ago - Lockheed Martin is seeking a Mission Strategy and Advanced Capabilities Director (Senior Manager) for Communications Systems. This role involves leading strategy development, technology progression, and new business capture across various communication missions. You will...Full time
- ...AI. What you will do: As Director of Product Strategy and Partner... .../Product functions (OEM, white label, acquire) and across the breadth of back-end systems and teams (Pricing, GTM, IT, CISO... ...cloud deployments, including compliance considerations relevant to DORA...Permanent employmentContract workFlexible hours
Teradata
Denver, CO3 days ago - ...Role: Investment Systems QA Lead (Aladdin / Charles River exp) Location: Denver, CO (Onsite) Overview We are seeking an experienced Test Coordinator with hands-on experience in investment management platforms such as BlackRock Aladdin and/or Charles...
AceStack LLC
Denver, CO3 days ago $160k - $190k
...world with inertial fusion! As a Shot Director (Senior Test Engineer) , you serve as the... ..., you lead shot execution, coordinating system leads, operators, diagnostics, and safety... ...to ensure operational readiness, compliance with operating limits, and successful test...Permanent employmentTemporary workPart timeFixed term contractLocal areaFlexible hoursShift work- ...hands-on leader in our Chief Compliance Officer ("CCO") with a focus... ...quarterly to the Board of Directors' Audit and Risk Committee, as... ...manage consumer compliance regulatory examinations and agency/investor... ...administrative and support systems, and internal reporting...Temporary workLocal area
Cornerstone Capital Bank
Denver, CO3 days ago - ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology... ...personnel, negotiate directly with authorities, and ensure compliance with regulatory requirements. The ideal candidate will be...
Confidential
Denver, CO18 days ago - ...office This position will report to the Director, Corporate Compliance and is primarily responsible for... ...and abuse laws and other health care regulatory laws that arise in the context of... ...are in place. Ability to use data and systems to help accomplish broader compliance...Full timeWork at office2 days per week
$113.4k
Overview Job Summary The Compliance Manager oversees United Rotorcraft’s (UR) defense and regulatory compliance initiatives, ensuring adherence to federal standards such... ...(BS/BA) in a Cybersecurity, Information Systems, Business, or related field from a four-year college...Contract workFor contractorsFor subcontractorWork at office$102k - $112k
...independently manages SIU responses to regulatory exams, audits, and program‑level information... ...submitting responses, and engaging with compliance, legal, and senior leadership as... ...compliance surveillance tools, investigative systems, and SIU resources, collaborating with Compliance...Work at officeRemote work$200k - $250k
Maximus is seeking a Senior Director of AI Systems Engineering to lead the AI & Data Accelerators portfolio. Responsibilities include architecting scalable AI systems and managing cross-functional teams. The ideal candidate should have a Bachelor's degree, over 12 years...Remote job- A leading building materials company based in Denver is seeking a Product Manager to oversee the lifecycle of a roofing products line. You will develop strategies, optimize profitability, and work collaboratively across departments including Sales, Operations, and Engineering...Work at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Regulatory Affairs - Compliance Systems & Labeling. Be the first to apply!
Related searches
- regulatory manager Denver, CO
- senior regulatory manager Denver, CO
- manager regulatory affairs Denver, CO
- head compliance Denver, CO
- finance compliance manager Denver, CO
- quality compliance manager Denver, CO
- compliance manager Denver, CO
- regulatory affairs director Denver, CO
- director quality compliance Denver, CO
- training and compliance manager Denver, CO