Senior Risk Management Manager (Molecular Assay, Instrument Hardware/Software)

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:

• Career development with an international company where you can grow the career you dream of .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save (~~~) student debt program and FreeU (~~~) education benefit - an affordable and convenient path to getting a bachelor's degree.

• 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.

• 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

This position works on site, in our Des Plaines, IL office location in the Abbott Molecular division.

What You'll Work On

The Risk Management Manager is responsible for routine supervision for currently two associates, and application of advanced risk management principles to evaluate and provide solutions to safety issues. Initiates and oversees the planning, organizing, performing, coordinating and/or directing of risk management work by subordinates, and may conduct performance evaluations. Applies an interdisciplinary, collaborative approach to plan, design, develop and verify a life-cycle balanced risk management approach which satisfies user / patient/ operational needs and statutory / regulatory requirements.

• Develop and execute project and process plans, implement policies and procedures, and set organizational/team goals.

• Translate goals into the day-to-day activities necessary to accomplish them.

• Identify and ensure appropriate utilization of personnel resources and tools needed for activity/project.

• Interprets regulations and requirements and develops procedural requirements to meet regulations.

• Develop and maintain relationships and partnerships with customers, stakeholders, peers, partners, and direct supervisory reports.

• Maintain compliance with regulatory agencies, quality system and project goals; ensures necessary documentation is in place to meet quality and regulatory requirements.

• Disseminate corporate-, division-, R&D CoE-, and site-related information to supervisory direct reports.

• Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units.

• Serves as a representative during internal and external inspections and inquiries from regulators such as FDA, ISO, and AQR as it relates to product Risk Management.

• Mentor, coach, and train risk management staff to prepare risk management deliverables.

• This role will also be expected to be lead Risk Management File Creation and Review

Required Qualifications

• Bachelor Degree in engineering or science related field or similar.

• Minimum 8 years of experience, both overall and any industry-specific experience needed.

• At least 2 years of experience leading audit reviews with regulatory agencies.

Preferred Qualifications

• Medical Device Experience is Preferred

• Management experience of least 1 year

• Creating and owning risk files

• At least 5 years in Risk Managment Field

• Experience complying with ISO 31000.

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ~~~ (~~~)

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 ~~~ , on Facebook at ~~~/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $125,300.00 - $250,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call ~~~ or email ~~~