Senior Manager Regulatory Affairs – Heart Failure (on-site)

Abbott; Atlanta (GA); On-site; USD 111,000 - 223,000; Full time

Job summary

An established industry player is seeking a Senior Manager of Regulatory Affairs to lead their dynamic team in Atlanta. This role involves managing regulatory strategies for innovative medical devices, fostering a diverse workplace, and ensuring compliance with industry standards. The company offers a supportive environment for professional growth, with excellent benefits, including medical coverage and tuition reimbursement. Join a forward-thinking organization that values your contributions and supports your career aspirations while making a meaningful impact in healthcare.

Benefits

Free medical coverage

Retirement savings plan

Tuition reimbursement

Flexible work environment

Career development opportunities

Qualifications

• 9+ years of regulatory affairs experience with a focus on compliance and leadership.
• Strong understanding of regulatory requirements for US and international markets.

Responsibilities

• Manage and lead the Regulatory Affairs department to meet corporate objectives.
• Develop regulatory strategies and ensure compliance with FDA and other regulations.

Skills

Regulatory Affairs Management

Leadership

Analytical Thinking

Problem-Solving

Communication Skills

Education

Bachelor's Degree in a related field

Master's Degree

Tools

QSR Standards

ISO Standards

EN Standards

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

1. Career development with an international company where you can grow the career you dream of.
2. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
3. An excellent retirement savings plan with high employer contribution.
4. Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
5. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
6. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

We are seeking a Senior Manager Regulatory Affairs to join Abbott’s Heart Failure Division on-site in our downtown Atlanta office.

This new team member is responsible for the management and leadership of the Regulatory Affairs department. The manager is responsible for allocating and managing department resources to accomplish department and corporate objectives.

What You’ll Work On

1. Recruits, coaches and develops organizational talent.
2. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
3. Creates an entrepreneurial environment.
4. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
5. May manage and coach a team of regulatory employees.
6. Keeps the organization's vision and values at the forefront of decision making and action.
7. Demonstrates effective change leadership.
8. Builds strategic partnerships to further departmental and organizational objectives.
9. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
10. Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
11. Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
12. Develops, monitors and appropriately adjusts the annual budget for department(s).
13. Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
14. Assess proposed regulations and communicate new requirements to the organization.

Required Qualifications

1. Bachelor’s Degree in a related field or an equivalent combination of education and experience.
2. Minimum 9 years related work experience.
3. Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
4. Monitors costs of projects and of human and material resources within a department or unit.
5. Monitors company-wide indicators such as market share and profitability.
6. Monitors external environment in area of technical or professional responsibility.
7. Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.
8. Facilitates others' participation in the continuous improvement program.
9. Investigates and solves problems that impact work processes and personnel within or across units or departments.
10. Develops and communicates a vision for the organizational unit assigned.

Preferred Qualifications

1. Master’s degree.
2. Submission / registration types and requirements.
3. Experience working with Class III implantable devices.
4. Effective verbal and written communication with diverse audience and team.
5. Analytical thinking with good problem-solving skills.
6. Experience managing and leading a team.
7. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
8. Must be able to lead and manage multiple and competing priorities and manage programs.
9. Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
10. Experience with medical device software requirements and software regulations.
11. Ability to identify risk areas and escalate issues as appropriate.

Apply Now.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

The base pay for this position is $111,300.00 – $222,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer. Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email [e-mail].