SR HEALTH AUTHORITY REPORTING CLINICIAN

Abiomed a member of the Johnson & Johnson Family of Companies is currently recruiting for Senior Health Authority Reporting Clinician! This position will be located in Danvers, MA.
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 https://www.
nj.
om/.
Position Summary.
The purpose of the Customer Quality Clinician is to review and process product complaints received through various communication modalities and contribute to complaint management system in accordance with internal and external complaint handling procedures while demonstrating world-class customer support.
Focus areas are Regulatory Reporting to FDA under 21 CFR, Part 803, Vigilance reporting per Regulation (EU) and MED DEV , Device Specific Vigilance Guidance, other relevant regulations as appropriate and management of Health Authority Requests.
Duties & Responsibilities may vary depending on the OpCo the individual is assigned to.
As applicable, Operating Companies will ensure they have adequate staffing including having individuals capable of providing Medical Judgement in relation to reportability determinations Key Responsibilities.
Demonstrate world class customer support and maintain knowledge of relevant OpCo’s products and services Provide Clinician Subject Matter Expert (SME) support and training across all OpCos.
Provide project support where needed.
Document clinical conclusions regarding the reportability assessment in the complaint record; utilize MD Workflow reports to identify tasks and manage common Email inboxes as applicable Determine device “Relatedness” to event (complex cases) Interface with MSOs Participate/Lead in Adverse Event (AE) Reviews Participate/Lead in the Reportability Matrices process o Participate/Lead in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities Represents clinical interests in multi-disciplinary teams during product development Act as Point of Contact for questions & device patient safety escalations Assess specific complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and CQ expectations.
This may include the review of selected codes product experience and patient codes for accuracy as well as maintaining and improving established coding guidelines to ensure consistency and accuracy with coding and reporting events.
Make regulatory reporting determinations on applicable files for one or more Business Units and being able to file relevant regulatory reports Execute file reviews and assess patient medical records, making and/or reassessing MDR and/or MDV decisions and managing complaint files and maintenance of reportable malfunction lists and associated documentation.
o Appropriately utilize risk management documentation to support the complaint’s regulatory reporting process Manage Standard and non-Standard Health Authority Requests of Health Authorities including justifications for non-reporting in accordance with FDA and EU regulations as applicable Lead support for regulatory additional information requests and actively supporting compliance audits Lead/Actively participate in audit and compliance review processes Maintain a full understanding of current Customer Quality and other independent quality system policies and procedures Participate/Lead in assigned projects towards desired business outcomes Participate/Lead the onboarding training of new associates and/or existing associates learning a new product as applicable Partner with and influence with stakeholders both internally and externally to drive needed change and/or execution of complaint related matters Responsible for communicating business related issues or opportunities to next management level Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed Qualifications Education.
A minimum of a Bachelors or equivalent University degree is required with a focus in Nursing, Life Sciences or Health Sciences or other medically qualified professional preferred.
Required.
Minimum of 2 years clinical experience in either a Cardiac Intensive Care Unit /Stepdown Unit or Cardiac Catheterization Lab.
A minimum of 4-6 years relevant work experience.
Investigative & analytical critical thinking skills.
Knowledge of applicable quality, FDA (Food & Drug Administration); Medical Device Directives/ Regulation & ISO (International Organization for Standardization) requirements.
Knowledge of human anatomy, medical terminology and products of applicable Business Units.
PC computer skills, MS Windows, MS Office (MS Outlook, Word, Excel, PowerPoint) and other communication tools such as Microsoft Teams, Skype, Zoom etc.
Strong written and verbal communication skills.
Fluent spoken/written English required.
Strong decision-making skills – able to make sound business decisions with sometimes limited information Ability to work in a cross-functional and matrix environment Ability to work independently Continuous Improvement focus Time management.
Ability to handle multiple priorities/ sudden changes in priorities Ability to work in stressful/fast paced environment Ability to work and interact with co-workers to accomplish company goals in a team environment Analytical/Problem Solving Skills Ability to learn Strong attention to detail Preferred.
A current RN license or an advanced practicing license (i.
.
PA, APRN, etc) Other.
This position may require 10% domestic travel.
This will be a fully onsite Monday-Friday position ·- This position has an estimated annual salary of USD$ - Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k).
-This position is eligible to participate in the Long Term Incentive program.
Employees are eligible for the following time off benefits.
Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.