American Red Cross N/A Senior Director of Regulatory Affairs (work from home) (2023)

internal number:RC63475

**** As a condition of working with the American Red Cross, you must provide certification that you are fully vaccinated against COVID-19 or eligible for an exemption, except in states where prohibited by law. Therefore, employment requires proof of vaccination or an approved waiver prior to commencement of employment****
Join us and your career will be a force for good!
job description:

Why choose us?
As one of the nation's leading humanitarian organizations, the American Red Cross is dedicated to helping those in need in the United States and partners with other Red Cross networks around the world. When you join our team, you have a direct impact on a meaningful mission and save lives every day. If you share our passion for helping others, join us for this great job opportunity. Work where your career becomes a force for good.

We are committed to a diverse workforce and to delivering our programs and services in a culturally competent manner that is consistent with the communities we serve. Our work environment is collaborative, respectful and inclusive, with an emphasis on building partnerships and a culture of belonging that empowers all team members. Come learn, grow and succeed while sharing your passion for making a difference.

The Red Cross supports a variety of cultural and community resource groups for workers and volunteers. From the Resource Network, Asian American and Pacific Islander Resource Group, Latino Resource Group, and PRIDE Red Cross, to the Umoja African American Resource Group, Veterans+ Resource Group, and Women's Resource Group, these networks provide connections, guidance, and assistance Express concerns and critical comments.

At the American Red Cross, your uniqueness shines!

What you need to know (job summary):

American Red Cross Biomedical Services

The American Red Cross Biomedical Service Quality and Regulatory Affairs Division contributes to the mission of the Red Cross by partnering with functional areas to develop quality, compliance, and regulatory strategies. We are currently looking for a Regulatory Affairs Program Manager. Reports directly to the Executive Director, Regulatory Affairs and Compliance.

Regulatory Affairs Program Manager,

Contributes to the development, implementation and enforcement of strategies to ensure compliance with Red Cross regulatory obligations, including government regulatory standards and agency guidance.
Advises the CEO on key regulatory issues facing the Institutional and Regulatory Affairs departments.
Collaborate with all Biomedical Services functional groups to define regulatory strategies and coordinate submissions at business unit level.
Serves as the regulatory affairs liaison between the American Red Cross and various government agencies and regulatory agencies, including the FDA.
May act as representative of the Executive Directors as appropriate.

If your profession is a force for good (primary responsibilities):

Support the Regulatory Affairs function, including regulatory filings such as product license applications, and ensure that all regulatory communications, especially those related to compliance, are tracked.
Coordinate and prepare documentation packages for regulatory submissions from all areas of biomedical services, including facility registration, blood product and IVD device license/supplement applications, and inquiries.
Lead strategic analysis and development of responses to FDA Form 483 and other regulatory inspection or audit reports.
Serve as the regulatory liaison to the project team throughout the product lifecycle.
Define regulatory requirements and develop regulatory approaches to support implementation and optimization efforts to increase sales in specific regions and overall impact on biomedical businesses.
Provide strategic direction to project teams to develop submissions and consult with regulators.
He is responsible for reviewing new or revised regulatory or guidance documents and is responsible for developing and submitting Red Cross comments to the appropriate regulatory agencies.
Facilitates the analysis and implications of proposed federal and state regulations and advises senior/executive management on these matters.
Represents the American Red Cross before the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), government agencies, and trade associations.
Monitor and ensure labeling of promotional materials complies with FDA regulations.

What you need to be successful (minimum qualifications):

• Education: 4-year college degree or equivalent combination of education and experience in the biological sciences, laboratory sciences, public policy or related fields.
• Experience: A minimum of 10 to 15 years is required. Experience preparing FDA submissions (biologic clearance applications, IVD medical device submissions)
• Basic Functional/Physical Requirements: Depending on job assignment, general outpatient skills sufficient to visit other sites may be required. Or be able to stand, walk, and carry (lift, carry, move) light to moderate weight, weighing no more than 20 lbs. Good hand-eye coordination, arm, hand, and finger dexterity are required, including the ability to grasp and the vision to use a keyboard, operate equipment, and read technical information. General mobility is essential.
• It may include sitting for long periods of time, driving a vehicle, and working in difficult conditions.
• Working Conditions: Work is performed indoors and may expose you to health and safety hazards associated with emergency service assistance work. You can travel to and attend meetings and conventions within the jurisdiction of your chapter, state and Red Cross system. Because the Red Cross is a disaster relief organization, staff may be required 24 hours a day during major disasters.

Salary Information: The salary range for this position is $108,900 to $145,200.

Note that the American Red Cross determines salary ranges based on the specific geographic location where the work is performed. The salary ranges mentioned in this article are averages. Specific salary information will be shared during the phone evaluation based on your location and qualifications.

Benefits for you:
We take care of you, and you take care of others. As a mission-driven organization, we believe our teams need a lot of support to do great work. Our comprehensive benefits help you balance family and work. With our resources and benefits, you have incredible opportunities to further your studies at the American Red Cross.

• Medical, dental and vision plans

• Healthy Spending Accounts and Flexible Spending Accounts

• PTO + vacation

• 401,000 for a 4% match rate.

• Paid Family Leave

• Staff assistance

• Disability and insurance: short term + long term

• Service awards and recognition

Apply now! Joining our team gives you the opportunity to make a difference every day.
The American Red Cross is an equal opportunity/affirmative action employer. All qualified applicants will be considered for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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Interested in volunteering?

Life's emergencies don't stop, and neither will the American Red Cross volunteers who make up more than 90 percent of our workforce, helping to prevent and alleviate human suffering. You can make a difference by volunteering in a position you love and applying your unique skills and talents. The Red Cross has generous volunteers who donate their time and talents to help our mission of saving lives.

What you need to be successful (minimum qualifications):

• Education: 4-year college degree or equivalent combination of education and experience in the biological sciences, laboratory sciences, public policy or related fields.
• Experience: A minimum of 10 to 15 years is required. Experience preparing FDA submissions (biologic clearance applications, IVD medical device submissions)
• Basic Functional/Physical Requirements: Depending on job assignment, general outpatient skills sufficient to visit other sites may be required. Or be able to stand, walk, and carry (lift, carry, move) light to moderate weight, weighing no more than 20 lbs. Good hand-eye coordination, arm, hand, and finger dexterity are required, including the ability to grasp and the vision to use a keyboard, operate equipment, and read technical information. General mobility is essential.
• It may include sitting for long periods of time, driving a vehicle, and working in difficult conditions.
• Working Conditions: Work is performed indoors and may expose you to health and safety hazards associated with emergency service assistance work. You can travel to and attend meetings and conferences within the jurisdiction of your chapter, state and Red Cross system. Because the Red Cross is a disaster relief organization, staff may be required 24 hours a day during major disasters.