DaVita means “to give life,” reflecting our proud history as leaders in dialysis—an essential, life-sustaining treatment for those living with end stage kidney disease (ESKD). Today, our mission is to minimize the devastating impacts of kidney disease across the full spectrum of kidney health care. At DaVita, we’re a community first and a company second. We care for our teammates with the same intensity with which we care for our patients—and encourage our teammates to bring their hearts to work. That is, we can be the same people inside and outside of work because for us, it’s not work, it’s our passion. Interested in joining our Village? There are over 75,000 careers and counting. Visit careers.davita.com to start your career adventure.

Posting Date

06/26/2025

6902 Se Lake RdSte 100, Milwaukie, Oregon, 97206-4546, United States of America

At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work.

We are seeking a Manager, Regulatory Affairs to assist with the operational excellence initiatives for the DaVita Clinical Research team. This teammate will be responsible for managing all activity related to clinical trials regulatory compliance as well as collaborating with management on proactive regulatory strategies.

DCR prides itself on a culture of growth, transparency and feedback and would want our leaders to do that same. We want a teammate who is compassionate, purposeful and motivated by meaningful work.

ESSENTIAL DUTIES & RESPONSIBILITIES:

40% - Manage and oversee clinical trials regulatory activities throughout the course of all studies.
- Provide oversight of DCR clinical trials Regulatory Affairs Coordinators for assigned projects and manage resources to ensure project needs are met.
- Act as a main point of contact for information and escalation for issues related to site start-up
20% - Develop and maintain clinical trials regulatory strategy and processes
- Develop start-up & submission strategies in conjunction with sponsor and project manager and ensure start-up deliverables are completed within agreed project timelines and in accordance with sponsor’s expectations.
- Provide regulatory expertise to assist project management team to develop initial and ongoing project timelines.
- Ensure all appropriate regulatory requirements are met and that documents meet both sponsor requirements and the FDA Code of Federal Regulations.
10% - Collaborates with management on proactive regulatory strategies based on industry trends and FDA guidance and citations.
- Provide regulatory insights into protocols and budgets.
- Identify areas of regulatory complexity or challenges and offer solutions to execute compliant regulatory start-up.
15% - Provide guidance and coaching to regulatory teammates in areas including company goals, regulatory and site start-up, and personal/career development
10% - Manage overall regulatory tracking in internal systems and reporting of project statuses, deliverables and metrics to sponsors and internal management.
5% - Other duties as assigned

MINIMUM QUALIFICATIONS

High School Diploma is required
BS/BA strongly preferred
Minimum of 4 years of Clinical Research experience
Basic computer skills: Microsoft Word, Excel, PowerPoint
Deals with confidential information and/or issues using discretion and judgment.
Travel required, approximately 10% depending on business needs
Excellent verbal and written communication and interpersonal skills and superior organizational and planning skills
Excellent communication, collaboration and team building skills
Knowledge of ICH GCP and Federal Regulations required

DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita. DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network. For 30 years we have helped 500+ clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US.

What We’ll Provide:

More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings.

Flexible weekly work schedule: This will vary and is based on current business needs
December Industry wellness break (Week between Christmas and New Year’s Day)
Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out
Support for you and your family: Family resources, EAP counseling sessions, access Headspace®, backup child and elder care, maternity/paternity leave and more
Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita’s online training platform StarLearning.

Here is what you can expect when you join our Village:
• A "community first, company second" culture based on Core Values that really matter.
• Clinical outcomes consistently ranked above the national average.
• Award-winning education and training across multiple career paths to help you reach your potential.
• Performance-based rewards based on stellar individual and team contributions.
• A comprehensive benefits package designed to enhance your health, your financial well-being and your future.
• Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation.

Salary/ Wage Range

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at https://careers.davita.com/benefits

Join us as we pursue our vision "To Build the Greatest Healthcare Community the World has Ever Seen."
Why wait? Explore a career with DaVita today.
Go to http://careers.davita.com to learn more or apply

#LI-JD2

At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.

This position will be open for a minimum of three days.

Salary/ Wage Range

$82,000.00 - $121,000.00 / year

If a candidate is hired, they will be paid at least the minimum wage according to their geographical jurisdiction and the exemption status for the position.

• New York Exempt:
•　New York City and Long Island: $64,350.00/year
•　Nassau, Suffolk, and Westchester counties: $64,350.00/year
•　Remainder of New York state: $60,405.80/year

New York Non-exempt:
•　New York City and Long Island: $16.50/hour
•　Nassau, Suffolk, and Westchester counties: $16.50/hour
•　Remainder of New York state: $15.50/hour


Washington Exempt: $77,968.80/year

Washington Non-exempt:
•　Bellingham: $17.66/hour
•　Burien: $21.16/hour
•　Unincorporated King County: $20.29/hour
•　Renton: $20.90/hour
•　Seattle: $20.76/hour
•　Tukwila: $21.10/hour
•　Remainder of Washington state: $16.66/hour

For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at https://careers.davita.com/benefits

Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

Manager, Regulatory Affairs (DCR)

Offer summary

Qualifications:

Key responsibilities:

Job description

Required profile

Experience

Hard Skills

Other Skills

Regulatory Affairs Manager Related jobs

Regulatory Affairs Manager

Regulatory Affairs Specialist (0-3)

Senior Regulatory Affairs Specialist

Manager, Regulatory Affairs (DCR)

Regulatory Affairs Manager