Senior Post Market Surveillance Specialist

Job Title Senior Post Market Surveillance Specialist (Santa Clara, California, United States of America) Job Function Quality Job Category Professional Job Description 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. 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. Ensure 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 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. Required Skills Audit Management Business Savvy Coaching Communication Compliance Management Continuous Improvement Fact-Based Decision Making ISO 9001 Issue Escalation Problem Solving Quality Control (QC) Quality Management Systems (QMS) Quality Standards Regulatory Environment Standard Operating Procedure (SOP) Preferred Skills Audit Management Business Savvy Coaching Communication Compliance Management Continuous Improvement Fact-Based Decision Making ISO 9001 Issue Escalation Problem Solving Quality Control (QC) Quality Management Systems (QMS) Quality Standards Regulatory Environment Standard Operating Procedure (SOP) Benefits and Pay Base pay range: $109,000.00 - $174,800.00 Vacation - 120 hours per calendar year Sick time - 40 hours per calendar year (40 hours per calendar year for employees who reside in the State of Colorado; 56 hours per calendar year for employees who reside in the State of Washington) 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 (10 days) Volunteer leave - 32 hours per calendar year Military spouse time‑off - 80 hours per calendar year Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr