Director, Regulatory Affairs (Medical Devices)
$195k - $245kSystem One
Job Description
Job Description
Director, Regulatory Affairs (Medical Devices) Medical Device | Global Scope | Denver Metro (Hybrid) Compensation: $195,000–$245,000 base + 30% target bonus (Compensation aligned to experience, scope, and market benchmarks.) The Opportunity A well-established and growth-oriented medical device organization is seeking a strategic regulatory leader to guide global regulatory affairs and labeling strategy across a diverse product portfolio. This role offers the opportunity to shape regulatory direction at the executive level while driving product approvals, lifecycle management, and global compliance initiatives. This is a highly visible leadership position supporting innovation from early development through commercialization and post-market compliance. Location Requirement: Candidates must reside in the Denver metro area to support a hybrid work model. What You’ll Lead
Ideal Background We’re seeking a regulatory executive who combines strategic vision with operational depth. Required Experience:
Preferred Experience:
Leadership Profile Successful candidates will demonstrate:
Additional Details
Ref: #568-Clinical
$177k - $266k
...the development and execution of global regulatory strategies for a diverse portfolio of... ...patient-specific and additively manufactured medical devices, including implantable solutions,... ...· 12+ years of progressive Regulatory Affairs experience with 5+ the medical device industry...Medical deviceWorldwideFlexible hours- ...As Director of Regulatory Affairs - Compliance Systems and Labeling, you'll direct regulatory and labeling activities and collaborate with senior... ...experience with increasing responsibility in the medical device or pharmaceutical industry. • Experience with both...Medical device
MRINetwork
Denver, CO3 days ago $230k
...Description Job Summary Manages all regulatory activities for the company.... ...ideally for both pharmaceutical drug‑device combination products and medical devices. Excellent written and verbal... ...pharmaceutical industry with direct regulatory affairs experience with drug/device...Medical device- ...driving our mission forward. As a global medical technology leader for nearly 100 years,... ...seeking an ambitious Senior Manager of Regulatory Affairs, Domestic, to spearhead our United... ...maintenance, ensuring our life-changing medical devices reach patients without delay. As a key...Medical deviceFull timeFlexible hoursNight shift3 days per week
$138.7k - $215.1k
The Senior Manager Regulatory Affairs provides senior-level leadership for global regulatory strategy and execution for new, modified, and marketed CONMED medical devices. Directs regulatory submission strategy, agency engagement, labeling and claims review, product lifecycle...Medical deviceWork experience placementWork at office- Morgan Stanley is looking for a candidate for a pivotal leadership role in regulatory strategies for personalized healthcare in Littleton, Colorado. The successful candidate will manage a team, drive regulatory excellence, and ensure compliance within a dynamic environment...Medical device
- Zimmer Biomet is seeking a Senior Manager of Regulatory Affairs, Domestic, to lead the US regulatory footprint. This role directs cross... ...ensuring timely registrations, quality system alignment, and robust regulatory pathways for medical devices. #J-18808-Ljbffr Zimmer BiometMedical device
- ...Corporation in Littleton, Colorado, is seeking a Manager with Direct Reports to lead the global regulatory strategy for a portfolio of additively manufactured medical devices. In this pivotal role, you will ensure compliance with evolving regulations, drive alignment...Medical deviceFlexible hours
$146k - $211k
...experience required, preferably in a global pharmaceutical or medical device company Sunshine Act and transparency reporting experience... ...Experience working with Commercial and Medical Affairs functions Experience managing compliance and ethics investigations...Medical deviceWork at office- ...orthopedic company headquartered in Westminster, Colorado, seeks a Global Head of Product, Regulatory and Compliance Legal to guide the company through FDA-regulated medical device development and commercialization. You will provide strategic legal counsel across product...Medical deviceWorldwide
$281k - $344k
...worldwide. Cerapedics has two drug-device products approved by the FDA... ...as a Global Head of Product, Regulatory and Compliance Legal. In... ...with marketing, sales, medical strategy, medical education,... ...Medical Strategy and Medical Affairs team members to create solutions...Medical deviceWork at officeWorldwide- ...Sr Electrical Engineer – Medical DevicesAre you an engineer who thrives on solving complex problems in the medical device industry? Do you often find you are most successful in a work environment that challenges your strong intellectual curiosity? We have an exciting...Medical device
Heyer Expectations
Littleton, CO4 days ago - Zimmer Biomet, a global medical technology leader, seeks a Clinical Engineer I to monitor, develop, and improve operational processes for patient-matched devices. You will create virtual surgical plans and guide designs, review imaging, and collaborate with surgeons to...Medical device
$32 - $55 per hour
...leader. Education and experience A high school diploma or equivalent experience 6+ years experience in the biopharmaceutical or medical device industry AA or AS in a Life Sciences or Engineering discipline preferred Physical Requirements Prolonged periods of sitting at...Medical deviceShift workNova Pneuma
Denver, CO19 hours ago- ...an experienced R&D Engineer to drive EU MDR compliance, design control and documentation across the medical device lifecycle. You will collaborate with Regulatory Affairs, QA, Clinical, and Manufacturing to ensure safe, effective devices meet EU MDR requirements. The...Medical deviceRemote job
- ...II may serve as technical advisor to the medical and clinical staff in the safe operation... ...Management Plan (MEMP), including all regulatory agency compliances and other applicable... ...complete and accurate inventory of medical devices, including trial and evaluation, rental,...Medical deviceFor subcontractor
TriMedx
Aurora, CO1 day ago - ...who give possibilities purposeBD is one of the largest global medical technology companies in the world. Advancing the world of health... ...continuous noninvasive blood pressure monitoring and/or tissue oximetry devices utilized in outpatient surgeries. These products assist in...Medical deviceFull timeTemporary work
- ...lives. Join us and be part of our inspiring journey.We are rewriting the playbook on heart failure treatment. We're not just a medical device company; we're trailblazers on a mission to redefine healthcare.Our star player? The Cordella PA Sensor and Heart Failure System...Medical deviceFull timeWork experience placementNight shift
$83k - $100k
...concept to launch. Ideal candidates will have a B.S. in Mechanical Engineering or related fields and 3-7 years of experience in the medical device industry, specifically orthopaedic devices. Proficiency in CAD design, particularly using SolidWorks, is essential. This full-...Medical deviceFull time$60k - $80k
...boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is... ..., and improving operational processes of patient- matched devices. This position involves the creation of virtual surgical plans...Medical deviceFor contractorsWork at officeFlexible hoursNight shift$325k - $430k
...with Marketing, Market Access, Medical Affairs, and Product Development.... ...adheres to all quality and regulatory expectations. Skills and Experience... ...within the Medical Devices / Neurostimulation industry.... ...national sales teams, including Director level positions and 2 levels...Medical deviceFlexible hoursLivaNova
Denver, CO2 days ago- Ceribell is seeking a Territory Manager to drive revenue growth across hospitals by educating ED, ICU, Neurology, and Administration on Ceribell’s non-convulsive seizure technology. You will manage relationships, close deals, and build a robust sales pipeline to exceed ...Medical device
- ...Senior Director of Strategic Alliances About the Company A contract development and manufacturing company serving medical device OEMs. Industry Medical Devices Type Privately Held About the Role The Company is seeking a Senior Director of Strategic...Medical deviceContract work
$30 per hour
...Electronics Medical Device Installer Electronics Material Handler I Medical Device Installation Support Location: Denver, CO 80218 (Multiple Area Hospital Sites) Pay: $30/hour Duration: One Week 08/28/2026-09/04/2026 Schedule: 8:00 AM Start | 810 Hour Shifts | 40 Hours...Medical deviceHourly payShift workDay shift- ...chairs and units ~ In lieu of above-mentioned qualifications and experience, 10 years of product management in dental or medical equipment/device industry experience may be considered ~ Preferred familiarity/relationships with current U.S. DSO customers and related...Medical deviceRemote workFlexible hoursNight shiftWeekend work
Planmeca USA
Denver, CO4 days ago $163.4k - $322.1k
...storytelling and team leadership The Team An evolving customer and regulatory landscape, mounting pipeline of next-gen assets and portfolio... ..., from biotechnology firms to global big pharma to medical device companies, to drive business value through end-to-end delivery...Medical deviceLocal areaFlexible hours- ...II may serve as technical advisor to the medical and clinical staff in the safe operation... ...Special Projects as assigned Regulatory Compliance 25% Ensure the accuracy and... ...complete and accurate inventory of medical devices, including trial and evaluation, rental,...Medical deviceFor subcontractor
$198.7k - $391.6k
...methodologies, and business trends The Team An evolving customer and regulatory landscape, mounting pipeline of next-gen assets and portfolio... ...—from biotechnology firms to global big pharma to medical device companies—to drive business value through end-to-end delivery...Medical deviceLocal area- ...Summary and Responsibilities As our Clinical Engineering Medical Device Security Engineer II, you will be a key architect of CommonSpirit... ...Conduct comprehensive security assessments and ensure regulatory compliance The job summary and responsibilities listed above...Medical deviceFull timeNight shift
Commonspirit Health
Englewood, COa month ago - ...Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; serves as a post-market vigilance (reportable event) and surveillance...Medical deviceWork at office
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