Top 30 Regulatory affairs Jobs in Aurora Co

Director of Research Operations and Education
Children's Hospital Colorado —Aurora, CO
- $137,944 - $229,907 a year
- Full-time
- Customer service
- Bachelor's degree
- Children
- Wellness program
- 403(b) matching
Quick Apply
Director, Regulatory Affairs
3D Systems —Littleton, CO
- $177,000 - $266,000 a year
- 11+ years
- Office
- Bachelor's degree
- Paid holidays
- Health insurance
Regulatory Compliance Officer
Partners Group —Broomfield, CO
- $130,000 - $160,000 a year
- Office
- 3 years
- Business development
- Disability insurance
- Health insurance
9d
Regulatory Affairs Specialist II
Cochlear Ltd —Lone Tree, CO
- $90,000 - $95,000 a year
- Online Application
- Hybrid work
- 6 years
- Office
- Bachelor's degree
- Employee stock purchase plan
- Disability insurance
4d
Environmental & Social Responsibility Project Coordinator
Corporate Functions —Denver, CO
- $64,800 - $81,000 a year
- Full-time
- Hybrid work
- Research
- Mid-level
- Master's degree
Quick Apply
2d
Senior Manager, Regulatory Affairs
CONMED —Greenwood Village, CO
- $138,700 - $215,100 a year
- Full-time
- ERP systems
- Office
- Ability to sit for extended periods
- Employee stock purchase plan
- Disability insurance
Quick Apply
10d
Sr Manager, Regulatory Affairs
Zimmer Biomet —Englewood, CO
- $120,000 - $150,000 a year
- Full-time
- 7 years
- Microsoft Outlook
- Office
- Wellness program
10d
Compliance Specialist I - DORA: PUC Hybrid
State of Colorado —Denver, CO
- $4,076 - $4,483 a month
- Online Application
- Hybrid work
- Background check
- Spanish
- Doctoral degree
- Paid holidays
- Disability insurance
4d
Regulatory Strategist Program Manager
University of Colorado —Aurora, CO
- $74,627 - $100,000 a year
- Overtime
- Hybrid work
- Background check
- Doctoral degree
- Customer service
- Disability insurance
- Health insurance
Senior Compliance Analyst - Advertising Reviewer (Hybrid)
Transamerica —Denver, CO
- $80,000 - $90,000 a year
- Full-time
- Hybrid work
- Marketing
- Research
- Mid-level
- Wellness program
- Paid parental leave
Product Security Process Analyst II
Terumo —Lakewood, CO
- $123,800 - $154,700 a year
- Computer Science
- 5 years
- Writing skills
- Wellness program
- Health insurance
4d
Project Manager (Energy & Permitting – Rockies Region) Remote/Hybrid
Tetra Tech —Denver, CO
- $95,000 - $150,000 a year
- Hybrid work
- Clean driving record
- 5 years
- Pass drug screening
- Life insurance
12d
Senior Manager, Clinical Operations
Cerapedics, Inc. —Westminster, CO
- $146,000 - $210,000 a year
- Remote
- Analysis skills
- Bachelor's degree
- Travel
- Disability insurance
- Health insurance
Quick Apply
Tissue Bank Coordinator (Open Rank, Entry to Senior)
University of Colorado —Aurora, CO
- $48,446 - $72,498 a year
- Overtime
- Background check
- Anatomy knowledge
- Medication administration
- Disability insurance
- Health insurance
Principal Scientist, Analytical Development - Process Science
ImmunityBio —Louisville, CO
- $150,000 - $165,000 a year
- Full-time
- 6 years
- Supervising experience
- Bachelor's degree
- AD&D insurance
- Disability insurance
Senior Manager, Research & Innovation (R&D)
Danone —Louisville, CO
- $118,000 - $169,000 a year
- Full-time
- Hybrid work
- Addiction Medicine
- Master's degree
- Bachelor's degree
- Wellness program
- Paid parental leave
Medical Science Liaison
Aytu Biopharma Inc —Denver, CO
- $180,000 - $190,000 a year
- Full-time
- Remote
- Medicine
- Office
- Analysis skills
Quick Apply
Director of Permitting
SOLV Energy, LLC —Denver, CO
- $150,080 - $187,600 a year
- Full-time
- Remote
- 7 years
- Engineering
- Travel
- Paid holidays
- Disability insurance
Quick Apply
12d
Open Rank Deputy Director Associate Professor or Professor
University of Colorado —Aurora, CO
- $150,000 - $500,000 a year
- Full-time
- Background check
- Medicine
- Customer service
- Disability insurance
- Health insurance
Medical Science Liaison/Senior Medical Science Liaison - Immunology and Targeted Therapy - West
EVERSANA —Denver, CO
- $190,000 - $220,000 a year
- Full-time
- Remote
- Medicine
- Doctor of Philosophy
- Travel
Quick Apply

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Director of Research Operations and Education

Children's Hospital Colorado -
Aurora, CO

Quick Apply

Job Details

Full-time
$137,944 - $229,907 a year

Benefits

Wellness program
403(b) matching
Paid parental leave
Health savings account
Disability insurance
Relocation assistance
Health insurance
Dental insurance
401(k)
Paid time off
Parental leave
Employee assistance program
Vision insurance
403(b)
Life insurance
Retirement plan

Qualifications

Bachelor's degree
Managing clinical research teams
General management
Hospital experience

Full Job Description

The Director of Research Operations and Administration is responsible for overseeing the operations and strategic growth of a large, multidisciplinary research organization which includes operational clinical research services (regulatory, clinical research coordination, and pre- and post-award financial management), administrative oversight of all clinical research activities including proposal submission, contracting, study start-up, invoicing and close-out, and the growth and maintenance of the clinical research infrastructure for the organization. The Director is responsible for developing and overseeing organizational strategy and goals, providing strategic leadership, building and modeling a high-performance culture with strong engagement within sub-departments.

Responsibilities:

Leads a multidisciplinary clinical research organization, partnering closely with both internal and external physicians and institutional leaders.
Oversees sub-departments including but not limited to: clinical research coordination and services, regulatory affairs, financial operations, project management, contracting, general administrative services, clinical research management system, internal awards programs, research nurses, and laboratory testing.
Supports investigator teams conducting research projects across the spectrum of sponsor types (e.g., governmental, non-profit, industry) and study types (both sponsor, and investigator initiated [including investigational drugs and devices]).
Utilizes knowledge of federal regulations and the legal and regulatory environment governing academic and/or clinical research administration to guide the execution of high-quality, safe, efficient and effective clinical research, with a strong focus on customer service, regulatory compliance, transparency and commitment to programmatic excellence and ongoing evaluation.
Facilitates support for intellectual property issues, e.g. technology transfer, licensing and commercialization issues in a non-profit, academic setting.
Participates in organizational strategic planning, and provides leadership in defining and implementing mission, vision, values, goals and priorities and measuring and reporting on progress.
Develops a high-performing management team and oversee recruitment, training, management and evaluation of all personnel, with a focus on building a high-performing, transparent and inclusive culture with strong employee engagement.
Develops and oversees and department and organizational budgets and financial performance.
Engages and collaborates with leaders across the organization, campus and partnering organizations to advance and improve clinical research operations.
Works in partnership with other departments and divisions to oversee hospital-wide research feasibility and start-up process, ensuring that research conducted at the institution meets regulatory, financial and legal requirements.

Minimum Qualifications

EDUCATION – Bachelor’s degree required

EXPERIENCE – Significant clinical research operations experience in hospital setting-8 or more years of experience in a healthcare setting with 5 or more years of management experience;research/scientific experience highly preferred

PREFERENCES:

Previous Director level experience supporting research operations within a system of care.
Previous leadership experience over a large, complex team of individuals.
Strong knowledge of clinical research operations including: regulatory, pre/post award financial management, proposal submissions, contracts, Phase 1 trials.

CERTIFICATION(S)– Clinical research and Lean/Six Sigma certifications preferred

Salary Information
Pay is dependent on applicant's relevant experience.

Annual Salary Range (Based on 40 hours worked per week): $137,944.29 to $229,907.13

Scope and Level

GUIDELINES: Guidelines are in the form of stated vision and objectives for the division. A second level manager directs and manages an operational and/or a functional area by developing objectives and strategies.

COMPLEXITY: Work assignment is unstructured and employee is responsible for implementing and managing a variety of objectives, resources, and strategies to achieve the goals of the division. Duties performed include operational and organizational planning, developing standards, schedules, priorities, guidelines, processes, measurement (evaluation) systems, implementation of production and performance management standards, and allocating resources.

DECISION MAKING: Employee is responsible for determining strategic structure, goals, objectives, and resources and for providing leadership for the division/department and the community it serves. Determines strategy priority shifts for the division/department.

CONTACTS/COMMUNICATIONS: Contacts are of a non-prescribed nature involving the negotiation and resolution of problems and where exceptional degrees of discretion, judgment, and knowledge are required. Contacts where the exchange of information, support, influence, and cooperation may have a very significant impact on the division, programs, and/or policies of the organization.

FINANCIAL ACCOUNTABILITY: Responsible for developing and overseeing organizational budgets in collaboration with other division leaders; manages cost center(s) appropriately to meet or exceed budget targets for productivity, salary and non-salary expenses.

SUPERVISION RECEIVED: Under executive direction, the employee is delegated personal responsibilities and authorities over a department. Work is reviewed for soundness of judgment and conclusion.

Benefits Information
Here, you matter. As a Children’s Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.

As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.

Children’s Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.

EEO Statement
It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information. The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of attendance at or graduation from an educational institution. You will not be penalized for redacting or removing this information.

Pay: $137,944.00 - $229,907.00 per year

Benefits:

401(k)
Dental insurance
Employee assistance program
Health insurance
Health savings account
Life insurance
Paid parental leave
Paid time off
Relocation assistance
Retirement plan
Vision insurance

Application Question(s):

Have you worked in healthcare before? If so, please explain the scope of your role including number of direct reports and number of studies your team manages.

Work Location: In person

Quick Apply

Refine Your Search

regulatory affairs jobs in aurora co

Director of Research Operations and Education

Director, Regulatory Affairs

Regulatory Compliance Officer

Regulatory Affairs Specialist II

Environmental & Social Responsibility Project Coordinator

Senior Manager, Regulatory Affairs

Sr Manager, Regulatory Affairs

Compliance Specialist I - DORA: PUC Hybrid

Regulatory Strategist Program Manager

Senior Compliance Analyst - Advertising Reviewer (Hybrid)

Product Security Process Analyst II

Project Manager (Energy & Permitting – Rockies Region) Remote/Hybrid

Senior Manager, Clinical Operations

Tissue Bank Coordinator (Open Rank, Entry to Senior)

Principal Scientist, Analytical Development - Process Science

Senior Manager, Research & Innovation (R&D)

Medical Science Liaison

Director of Permitting

Open Rank Deputy Director Associate Professor or Professor

Medical Science Liaison/Senior Medical Science Liaison - Immunology and Targeted Therapy - West

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