Senior Post Market Surveillance Specialist

Johnson Johnson; Cincinnati (OH); Hybrid; USD 90,000 - 115,000; Full time

Benefits offered by this job

J&J Flex hybrid program

Job summary

Johnson & Johnson is seeking a Senior Post Market Surveillance Specialist to be based in Cincinnati, OH, handling domestic and international product surveillance for medical devices. You will manage complaint workflows, determine reportability, and submit FDA and other regulatory reports.

The role emphasizes collaboration across Service, Sales, and Quality teams in a regulated ISO 13485 environment. The position requires 3+ years in quality within a medical device setting, strong organizational

Qualifications

• B.A./B.S. in Life Science, Engineering, or equivalent level.
• 3+ years in a commercial medical device company, preferably in Quality.
• 2+ years in complaint handling.
• Highly organized with ability to manage multiple activities and priorities.
• Familiarity with US FDA Regulations (21 CFR 803, 806, 820), EU Medical Device Regulations, ISO 13485.
• Excellent written and verbal communication; strong cross-functional collaboration.

Responsibilities

• Manage daily workflows for all assigned complaint records.
• Coordinate with Service and Sales to gather complaint details and event specifics.
• Determine reportability and submit regulatory reports to the FDA and other agencies.
• Perform Good Faith Effort for product return and collect required information.
• Review investigation records for complete analysis documentation.
• Ensure all applicable records are created and completed.
• Draft and communicate customer complaint response letters timely.
• Support internal/external audits and lab operations as needed.

Skills

Communication

Organization

Regulatory knowledge

Teamwork

Problem Solving

Quality Assurance

Education

B.A./B.S. in Life Science or Engineering

Job description

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: Cincinnati, Ohio, United States of America

Job Description

We are searching for the best talent for a Senior Post Market Surveillance Specialist to be based in Cincinnati, OH.

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 and regulatory reports. This position reports to the Senior Manager, Post Market Surveillance.

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.
• Support complaint investigations.
• Support lab operations and equipment management.
• 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.
• 3+ 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.

Location and Work Arrangement

This position is based in Cincinnati, OH and is eligible for our J&J Flex hybrid work program (minimum of 3 days on site per week). Relocation assistance is not available for this position.

Equal Opportunity Employment

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.

Inclusive Hiring Process

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 ([e-mail]) or contact AskGS to be directed to your accommodation resource.

Preferred Skills

• Audit Management
• Business Savvy
• Coaching
• Communication
• Compliance Management
• Continuous Improvement
• Fact-Based Decision Making
• ISO 9001
• Issue Escalation
• Problem Solving
• Quality Co