Senior Regulatory Affairs Specialist - International

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. 

• 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 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.
  

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose 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 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. 

The Opportunity

Our location in Sylmar, CA currently has an opportunity for a Senior Regulatory Affairs Specialist-China. As a Senior Regulatory Affairs Specialist, you are responsible for overseeing the approval process through China’s regulatory agency(NMPA) for Abbott’s Cardiac Rythm Management devices. This includes working with our counterparts located in China, acting as a liaison between China and US, and providing expert knowledge on regulatory matters. 

What You’ll Work On

• As the Senior Specialist in Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resourcewithin the organization in directing development of product registration submission, progress reports, supplements,and amendments.
• Interacts with regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Participates and improves processesforsome of the following: product development plan and implementation, regulatory strategy, risk management,

• Ensures timely approval of new medical devices, combination products, and continued approval of marketed products.
• Serves as regulatorycore team representative on product development efforts, and support  marketing, research teamsnd regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions,technical labeling, appropriate regulations and interpretations

Required Qualifications 

• Associates Degree (± 13 years)

• Minimum 7 years

Preferred Qualifications  

• Fluent in Mandarin

• Previous regulatory 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.

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

• Demonstrated ability to quickly learn new technology

• Knowledge of regulations.

• Excellent written and oral communication skills.

• Minimum 3 yearsregulatory affairs submission experience.

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