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Regulatory affairs Jobs in Lakewood, CO

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Regulatory affairs • lakewood 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

Director, Regulatory Affairs - Compliance Systems and Labeling

Terumo Blood and Cell TechnologiesDenver, CO, United States
$196,500.00 yearly
Full-time

Director, Regulatory Affairs - Compliance Systems and Labeling.As Director of Regulatory Affairs Compliance Systems and Labeling, you'll direct regulatory and labeling activities for Terumo Blood ... 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

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 & Clinical Specialist

LivaNovaDenver, CO, United States
Full-time

As a global medtech company, we are driven by our vision of changing the trajectory of lives for a new day and our mission to create ingenious solutions that ignite patient turnarounds.Our relentle... Show more

Supervisory External Affairs Specialist

US Government JobsDenver, CO, United States
Full-time

Supervisory External Affairs Specialist.This position is part of the Office of Indian Energy Policy and Programs, Department of Energy.As a Supervisory External Affairs Specialist, you will work wi... Show more

Manager, Government Affairs

WellPowerDenver, CO, United States
$99,008.00 yearly
Full-time

WellPower envisions a community where every person's mental health is fostered through strength, resilience and hope.We empower people to overcome barriers and achieve lasting well-being through co... Show more

Consultant, Rates & Regulatory

Black & VeatchEnglewood, CO, United States
Full-time +1

Consultant, Rates & Regulatory.Locations: Bloomington, MN, US; Los Angeles, CA, US; Walnut Creek, CA, US; Greenwood Village, CO, US; San Marcos, CA, US; Gaithersburg, MD, US; Chicago, IL, US; Burli... Show more

Senior Regulatory Compliance Analyst

Blue Prism GroupDenver, CO, United States
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

Supervisory Public Affairs Specialist

Internal Revenue ServiceDenver, CO, United States
Full-time

Exercise delegated managerial authority to oversee the overall planning, directing and timely execution of a program, several program segments (each of which is managed through separate subordinate... Show more

Regulatory Affairs & Public Policy, Senior Associate

Rowan Digital InfrastructureDenver, CO, United States
$90,000.00 yearly
Full-time

Senior Associate, Regulatory Affairs & Public Policy.Rowan Digital Infrastructure is looking for a Senior Associate, Regulatory Affairs & Public Policy to help support policy and regulatory executi... Show more

Director, Scientific Affairs

International Assn. for the Study of Lung CancerDenver, CO, United States
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

Supervisory External Affairs Specialist

Department of EnergyDenver, CO, United States
Full-time

Supervisory External Affairs Specialist.The Department of Energy's mission is to ensure America's security and prosperity by addressing its energy, environmental and nuclear challenges through tran... 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

Director, Regulatory Affairs

3D Systems, Inc.Littleton, CO, United States
$177,000.00 yearly
Full-time

Join a pivotal leadership role at the forefront of innovation in personalized healthcare and additive manufacturing.In this position, you will lead the development and execution of global regulator... 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 Affairs Specialist II

Zimmer Biomet HoldingsEnglewood, CO, United States
$60,000.00 yearly
Full-time

Regulatory Affairs Specialist II.At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward.As a global medical technology leader for nearly 100 years, a p... 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

Legislative & External Affairs Coordinator

Vault 44.01 LtdDenver, CO, United States
$100,000.00 yearly
Full-time

Legislative & External Affairs Coordinator.Legislative & External Affairs Coordinator to support the company's government relations, regulatory strategy, and community engagement functions across i... Show more

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Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

StrykerDenver, CO, United States
2 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.