Senior Post Market Surveillance Specialist

Johnson & Johnson MedTech; Cincinnati (OH); Hybrid; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Sick time – 40–56 hours depending on州

Job summary

Johnson & Johnson MedTech in Cincinnati, OH is seeking a Senior Post Market Surveillance Specialist to manage domestic and international product surveillance for all medical devices.

You will lead complaint handling, determine reportability to the FDA and other regulators, and support audits and investigations, reporting to the Senior Manager, Post Market Surveillance.

Qualifications

• BA/BS in Life Science or Engineering or equivalent experience.
• 3+ years in a commercial medical device company, preferably in Quality.
• Experience with FDA regulations (21 CFR 803/806/820), EU MDR and ISO 13485.

Responsibilities

• Manage daily workflows for all assigned complaint records.
• Determine reportability of complaints and submit regulatory reports to FDA and other agencies.
• Support complaint investigations and audits.
• Collaborate with Service, Sales, and Quality teams to gather event details.

Skills

Audit Management

Regulatory Knowledge

Communication

Problem Solving

Quality Management Systems

ISO 9001

Documentation

Cross-functional Collaboration

Education

BA/BS in Life Science or Engineering

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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.
• 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.

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

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)

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description For Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits