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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.

Associate Director, Medical Events Group

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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

As the Associate Director, Medical Events Group, you will ensure product quality and safety by providing medical surveillance and post market review for all division's products. Manage staff whose team is responsible for filing Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest of world for the division's products. Function as a representative during audits, inspections, assessments by regulatory agencies, e.g. FDA for the medical event reporting process, procedures and issues. Ensure that medical event reporting policies, procedures and processes are in place to meet global regulatory requirements. Provide metrics on medical events to support management of product quality issues.

What You’ll Work On

+ Primary liaison for identifying regulatory, risk management and legal issues and forwarding them to the appropriate organization for review.

+ Working with the division Medical Director, recommend strategy and implement process for global medical device and vigilance reporting for all ADC Products.

+ Implement reporting policies and procedures to capture and document all potential reportable events to meet global regulatory requirements.

+ Ensures that CFR 803, 806 and 820 as well as ISO 13485 are incorporated in the divisional policies procedures and processes.

+ Manage the Medical Event Group (MEG) and ensure compliance to the appropriate regulations as well as corporate and divisional procedures.

+ Accountable for the worldwide post market surveillance for ADC.

+ Responsible for ensuring appropriate filing decisions and timely reporting of Reportable Events in accordance with global regulatory requirements.

+ Interpret regulations and requirements and implement programs and procedures to meet these requirements worldwide.

+ Evaluates and helps resolve product issues that impact patient safety and/or management and highlight them to the appropriate management to assure safe and efficacious products in the field.

+ Provides quality, technical and compliance leadership and direction to the team. • Serves as a representative during audits, inspections, assessments by regulatory agencies, e.g. FDA, ISO and other regulatory body inspections for the medical event reporting/vigilance process, procedures and issues.

+ Responsible for the implementation of Quality metrics necessary to streamline processes for optimal efficiency and capture Quality data for use in the Quality Management Review presentation.

+ Serves as liaison to Medical Products Group too provide metrics and participate in regulatory strategies, comments on external standards and guidance that affect the MEG for the division.

+ Responsible for implementing and maintaining the effectiveness of the quality system.

Required Qualifications

+ Bachelors, Masters or PhD. in a related field

+ Minimum of 5 years of experience in Quality Systems, Quality Assurance and/or Regulatory Affairs

+ Medical device industry or other regulated environment experience required

+ Minimum 3 years of functional management or supervisor experience required.

Preferred Qualifications

+ Individuals with previous experience in Medical Events reporting will be prioritized.

+ Ability to manage multiple tasks and priorities.

+ Strong Microsoft Office capabilities

+ Ability to leverage and/or engage others to accomplish projects.

+ Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

+ Multitasks, prioritizes and meets deadlines in timely manner.

+ Strong organizational and follow-up skills, as well as attention to detail.

**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Diabetes

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The base pay for this position is $146,700.00 – $293,300.00. 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 224-667-4913 or email [email protected]