Associate Director, Medical Events Group
Associate Director, Medical Events Group
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 146700 - 293300
1 Vacancy
Job Description
JOB DESCRIPTION:
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. Youll 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 bachelors 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 were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were 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 divisions 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 divisions 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 Youll 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 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:
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 and on Twitter @AbbottNews.
Divisional Information
Medical Devices
General Medical Devices:
Our medical devices help more than 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine ngersticks.
Diabetes
Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.
The base pay for this position is
$146700.00 $293300.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Director
Employment Type
Full-Time
Key Skills
Similar Jobs
Dr. Job is an online platform that connects employers with skilled job seekers, facilitating the search for job opportunities and top talent. Established in 2015. Dr. Job Pro has emerged as the world premier job portal, attracting thousands of job seekers every day from all over the world.
Follow Dr.Job
Dr Job FZ LLC. 2025 © All Rights Reserved