Job Details

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'llalso have access to:

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

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with high employer contribution· Tuition reimbursement, the Freedom 2 Save student debt program andFreeUeducation benefit - an affordable and convenient path to getting a bachelor's degree.

• A company recognized asa great placeto 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.
  

For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whetherit'sglucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than10,000 peoplehave healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than500,000 peoplewith diabetes from routinefingersticks.

The Opportunity

Our location inSylmar, CA currentlyhas an opportunity for aSeniorRegulatory Affairs Specialist-China. As aSenior Regulatory AffairsSpecialist,youare responsibleforoverseeing the approval process through China's regulatoryagency(NMPA)for Abbott's Cardiac Rythm Management devices. This includes working with our counterpartslocatedin China,acting as a liaison between China and US, and providing expert knowledge on regulatory matters.

WhatYou'llWork On

• As theSeniorSpecialist in Regulatory AffairsSub-Function, considered ashighlyexperienced and knowledgeable resourcewithin theorganization in directing development of product registration submission, progress reports, supplements,andamendments.
• Interacts with regulatory agency toexpediteapproval of pending registration.
•Serves asregulatoryliaison throughout product lifecycle.
•Participatesandimproves processesforsome ofthe following: productdevelopmentplan and implementation, regulatory strategy, risk management,
.
• Ensurestimelyapproval of new medical devices, combination products,and continued approval ofmarketed products.
• Serves asregulatorycore teamrepresentativeon product development efforts, andsupportmarketing, researchteamsand regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions,technical labeling,appropriateregulationsand interpretations

Required Qualifications

• Associates Degree(± 13 years)

• Minimum 7 years

Preferred Qualifications

• Fluent inMandarin

• Previousregulatory compliance, R&D, and/or quality experience in medical device industry

• Good working knowledge of the product development process, quality management system, biocompatibility, software, and cybersecurity regulations.

• BachelorsDegree(± 16b years) OR An equivalent combination of education and work experience

• Demonstrated ability to quickly learnnew technology.

• Knowledge of regulations.

• Excellent written and oral communication skills.

• Minimum 3 yearsregulatory affairssubmissionsexperience.

• 4 or more years direct regulatory affairs submissions experience, submission experience to NMPA is a plus

• Expertisewith EDMS, publishing and/or registration management systems, AdobeAcrobatordemonstratedexperience with similar tools.