Senior Post Market Surveillance Specialist

Johnson & Johnson • Santa Clara, CA

2d • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

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

Responsibilities

• 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree