Post Market Specialist II

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

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:

Danvers Massachusetts United States of America

Job Description:

Location:

Danvers Massachusetts US 01923

Abiomed is a pioneer and global leader in healthcare technology and innovation with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers Massachusetts and offices in Baltimore MD Woburn MA Aachen & Berlin Germany and Tokyo Japan Abiomeds 2000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture passion for our work and a strong commitment to employee professional development.

Patients First Innovation Winning Culture Heart Recovery

The Post Market Complaint Specialist II is responsible for reviewing clinical and product complaints to assess for reportability in compliance with global medical device regulations. The candidate must have experience in medical device and post-market regulations with a solid understanding of complaint handling processes and adverse event follow-up.

Principle Duties and Responsibilities:

• Analyze and process complaints in a uniform and timely manner to ensure proper complaint coding and accurate complaint assessment.
• Completes assessments of product complaints to determine reportability and coordinates complaint investigations between the quality assurance department engineering customer support and other departments.
• Review all assigned clinical and product complaints for adverse events
• Interface with field reps. and clinical staff to acknowledge document and obtain detailed information regarding adverse events and incidents received by the company
• Apply knowledge of medical device regulatory requirements to support the reporting decision process and identify reportable events as they are received
• Perform data entry and prepare reports/ graphs related to special projects complaints and lot qualification as necessary.
• Complete Reportability Assessments in a timely manner in adherence with Abiomeds policies and procedures
• Identify possible trends related to complaints and present information or concerns to management using available programs and applications (e.g. PowerPoint Excel graphs charts)
• Escalate complex complaint issues per department policies and guidelines.
• Work closely with engineering investigation teams to ensure the timely closure of technical investigations
• Interact with cross-functional teams to obtain information pertinent to the complaint investigation
• Write customer letters

Job Requirements:

• Minimum 3 years of work experience processing complaints within the device and/or pharmaceutical/life-sciences industry
• Bachelors degree: Medical device experience preferred
• Demonstrated knowledge of global medical device and/or pharmacovigilance regulations
• Working knowledge/experience with domestic and international regulatory reporting requirements for medical devices (i.e. 21CFR 803 CMDR Meddev 2.12 etc.) (experience with PMDA highly preferred)
• Excellent written verbal & interpersonal communication skills
• Proficient in the use of Microsoft Office programs specifically Excel PowerPoint Word
• Approachable with a positive attitude
• Critical thinker
• Exceptional attention to detail in documenting events composing clinical narratives and editing quality documents
• Demonstrated ability to manage multiple competing priorities and meet deadlines
• Ability to work independently and as a team player
• Experience using a global complaint handling database or quality management system e.g. Trackwise Salesforce
• Possess strong complaint handling experience (i.e. 21CFR 820.198)

Applicants must provide proof that they are fully vaccinated with an FDA approved or authorized vaccine for COVID-19 or have a valid medical/religious exemption.

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race color religion gender gender identity national origin ancestry age sexual orientation gender identity marital or civil partnership status pregnancy gender reassignment non-job related mental or physical disability genetic information veteran status military service application for military service or membership in any other category protected under maintains a drug-free workplace.

Required Skills:

Preferred Skills:

Audit Management Business Behavior Coaching Compliance Management Continuous Improvement Data Analysis Detail-Oriented Goal Attainment Internal Controls Issue Escalation Problem Solving Process Oriented Quality Control (QC) Quality Management Systems (QMS) Quality Standards Regulatory Environment

The anticipated base pay range for this position is :

$79000.00 - $127650.00

Additional Description for Pay Transparency:

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



This position is eligible to participate in the Companys long-term incentive program.



Subject to the terms of their respective policies and date of hire employees are eligible for the following time off 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: - Experience:

IC