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Regulatory affairs Jobs in Thornton, CO

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Regulatory affairs • thornton co

Last updated: 2 days ago

Senior Regulatory Affairs Specialist

StrykerDenver, CO, United States
$91,600.00 yearly
Full-time

Senior Regulatory Affairs Specialist.Stryker is hiring a Senior Regulatory Affairs Specialist to support Sports Medicine in Denver, CO or San Jose, CA! In this role, you will develop and implement ... Show more

Regulatory Analyst

Colorado Department of TransportationDenver, CO, United States
$70,012.80 yearly
Full-time

This position is eligible for a hybrid and/or remote working arrangement.Hybrid positions are expected to be present at the office location for no less than one day per work week.CEO is seeking a R... Show more

Manager, Government Affairs

WellPowerDenver, CO, US
$99,008.00 yearly
Full-time

We empower people to overcome barriers and achieve lasting well-being through collaborative behavioral health care and comprehensive support.We honor people's identities, lived experience and journ... Show more

EH&S Specialist - Regulatory

SM EnergyDenver, CO, United States
Full-time

The EH&S Specialist is responsible for supporting the development and maintenance of a flexible inventory of drill-ready permits.This role ensures projects meet all applicable regulatory requiremen... Show more

Regulatory Change Management Analyst

Judi HealthDenver, CO, United States
$87,200.00 yearly
Full-time

Regulatory Change Management Analyst.Charlotte, North Carolina, United States; Denver, Colorado, United States; New York, New York, United States.Judi Health is an enterprise health technology comp... Show more

Open Rank Regulatory Affairs Coordinator (RAC) (Entry Senior)

The University of Colorado SystemDenver, CO, United States
$52,860.00 yearly
Full-time

Open Rank Regulatory Affairs Coordinator (RAC) (Entry Senior).The University of Colorado Division of Hematology, Clinical Trials Unit is seeking a Regulatory Affairs Coordinator.This position is r... Show more

Director - Environmental Affairs

SSR MiningDenver, CO, United States
Full-time

Director Environmental Affairs.USA, Turkey, Canada, and Argentina, combined with a global pipeline of high-quality development and exploration assets in the USA, Turkey, and Canada.SSR's commitmen... Show more

Regulatory Affairs Specialist

Terumo Blood and Cell TechnologiesDenver, CO, United States
Full-time

As a Regulatory Affairs Specialist, you'll play a key role in bringing innovative medical technologies to patients around the world.In this position, you'll support global product registrations, de... Show more

Manager, Regulatory Affairs

CONMED CorporationDenver, CO, United States
Full-time

The Manager, Regulatory Affairs leads regulatory strategy and execution for new and existing CONMED medical devices across domestic and international markets.This role manages regulatory submission... Show more

Senior Regulatory Compliance Analyst

Blue Prism GroupDenver, CO, United States
$45,000.00 yearly
Full-time

Senior Regulatory Compliance Analyst.SS&C combines proprietary technology with deep industry expertise to support complex financial and health care operations.Our teams design, implement, and opera... Show more

Manager, Regulatory Affairs

ConMedDenver, Colorado
Full-time

CONMED medical devices across domestic and international markets.This role manages regulatory submissions, agency interactions, labeling review, product lifecycle support, and cross-functional regu... Show more

Regulatory Analyst

Government JobsDenver, CO, United States
$70,012.80 yearly
Full-time

This position is eligible for a hybrid and/or remote working arrangement.Hybrid positions are expected to be present at the office location for no less than one day per work week.CEO is seeking a R... Show more

Director, Scientific Affairs

International Assn. for the Study of Lung CancerDenver, CO, United States
$125,000.00 yearly
Full-time +1

The Director, Scientific Affairs will provide operational and strategic oversight for scientific and clinical activities within the International Association for the Study of Lung Cancer's (IASLC) ... Show more

Senior Director, External Affairs

TractDenver, CO, United States
$175,000.00 yearly
Full-time

Senior Director Of External Affairs.Tract is a team of digital infrastructure experts dedicated to accelerating responsible data center growth by developing master-planned data center parks with ac... Show more

Senior Regulatory Compliance Analyst

SS&C Technologies HoldingsDenver, CO, United States
$45,000.00 yearly
Full-time

Senior Regulatory Compliance Analyst.SS&C combines proprietary technology with deep industry expertise to support complex financial and health care operations.Our teams design, implement, and opera... Show more

Manager, Regulatory Affairs

ConmedDenver, CO, United States
Full-time

The Manager, Regulatory Affairs leads regulatory strategy and execution for new and existing CONMED medical devices across domestic and international markets.This role manages regulatory submission... Show more

Senior Regulatory Compliance Analyst

SS&C TechnologiesDenver, CO, US
$45,000.00 yearly
Full-time

As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries.Some 20,000 financia... Show more

Regulatory Intern

GogoBroomfield, CO, United States
$18.40 hourly
Full-time

The Regulatory Intern (2026) internship requires a minimum availability of 15 hours per week during 2026 in Gogo's headquarters located in Broomfield, CO.Interns are full-fledged members of the tea... Show more

Director, Scientific Affairs

Mondadori Digital S.p.A.Denver, CO, United States
$125,000.00 yearly
Full-time +1

The Director, Scientific Affairs will provide operational and strategic oversight for scientific and clinical activities within the International Association for the Study of Lung Cancer's (IASLC) ... Show more

Senior Manager - Public Affairs

LivCor LLCDenver, Colorado, United States
$150,000.00 yearly
Full-time

The Senior Manager role will be a critical member of our Public Affairs team, responsible for identifying, assessing, and resolving complex issues across the business.The i... Show more

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Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

StrykerDenver, CO, United States
10 days ago
Salary
$91,600.00 yearly
Job type
  • Full-time
Job description

Senior Regulatory Affairs Specialist

Stryker is hiring a Senior Regulatory Affairs Specialist to support Sports Medicine in Denver, CO or San Jose, CA! In this role, you will develop and implement regulatory strategies, ensure compliance across the product lifecycle, manage regulatory submissions, advise stakeholders on regulatory requirements, and engage with regulatory authorities to resolve issues and support market access.

What you will do:

  1. Develop and update regulatory strategies at the local, regional, and global levels by monitoring regulatory intelligence and emerging requirements.
  2. Determine product classification, submission requirements, and approval pathways, preparing and submitting regulatory filings in alignment with applicable guidelines.
  3. Assess the regulatory landscape and provide guidance across the product lifecycle to support compliant development, manufacturing, and commercialization.
  4. Identify potential regulatory obstacles, anticipate upcoming issues, and recommend practical solutions to maintain compliance and support market access.
  5. Review quality, preclinical, and clinical documentation to ensure readiness for regulatory submissions and consistency with regulatory expectations and product claims.
  6. Evaluate proposed device modifications to determine necessary regulatory actions
  7. Support interactions with regulatory authorities by contributing to communication, tracking submission progress, and preparing required documentation.
  8. Provide regulatory input on product labeling and claims, ensuring that clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.

What you need:

Required:

  • Bachelors degree
  • Minimum of 3+ years of regulatory affairs experience within a regulated industry (e.g., medical devices, IVDs, pharmaceuticals, biotechnology, or healthcare products).
  • Demonstrated experience in project management, regulatory writing, and coordinating and executing regulatory submissions and deliverables.

Preferred:

  • Bachelors degree in Regulatory Science, or technical discipline (Engineering or Life Sciences)
  • Experience engaging with regulatory authorities to support submissions, respond to inquiries, and facilitate successful interactions throughout the product lifecycle.
  • RAC(s) certification

United States of America Pay Ranges:

  • US10: $91,600 - $152,700 USD Annual
  • US30: $108,300 - $180,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.