Senior Post Market Surveillance Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

We are searching for the best talent for a Senior Post Market Surveillance Specialist to be based in Santa Clara, CA.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Purpose: The Senior Post Market Surveillance Specialist is responsible for performing domestic and international product surveillance activities for all medical devices manufactured, marketed, distributed, and serviced by Auris Health, Inc. Primary responsibilities include activities associated with the complaint handling program, regulatory reports, and field actions.  This position reports to the Senior Manager, Quality Management System. 

You will be responsible for:

• Manage daily workflows for all assigned complaint records.

• Communicate with Service and Sales teams, or other internal personnel, to identify details related to complaint information and event specifics.

• Determine reportability of complaints and submit applicable regulatory reports to the FDA and other Regulatory Agencies, as applicable.

• Perform Good Faith Effort for product return and obtain required information for complaint assessment and evaluation.

• Review investigation records to ensure analysis documentation is appropriate and complete.

• Review complaint records to ensure all the applicable records are created and completed.

• Ensures customer complaint response letters are completed and communicated in a timely and comprehensive manner.

• Understand team performance metrics and strive to achieve targets and goals.

• Perform ad hoc reporting and researching of post market data.

• Manage and coordinate documentation for field actions, as required.

• Support and participate in internal and external audits.

• Other related duties may be assigned.

Qualifications/Requirements:

• Preferred: B.A./B.S. in in a Life Science, Engineering, or similar degree, or equivalent combination of education and experience.

• 5+ years of experience in a commercial medical device company, preferably within Quality. 2+ years in complaint handling.

• Must be highly organized with the ability to manage multiple activities simultaneously and effectively prioritize projects and tasks.

• Familiarity with the applicable US FDA Regulations (21 CFR Part 803, 806, 820), EU Medical Device Regulations, and ISO 13485 standards.

• Excellent written and verbal communication skills.

• An approachable individual who provides a high level of teamwork and cross-functional collaboration.

• Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, rel