Senior Regulatory Affairs Specialist - International

Senior Regulatory Affairs Specialist-China

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 resource within 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 processes for some 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 regulatory core team representative on product development efforts, and support marketing, research teams and 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 ( 16 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 years regulatory affairs submissions experience.

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

Expertise with EDMS, publishing or registration management systems, Adobe Acrobat or demonstrated experience with similar tools.

The base pay for this position is $86,700.00 $173,300.00. In specific locations, the pay range may vary from the range posted.