Post Market Surveillance Manager- Shockwave Medical

Johnson & Johnson • Santa Clara, CA

62d

About The Position

Johnson & Johnson is hiring for a Post Market Surveillance Manager - Shockwave Medical to join our team located in Santa Clara, CA. 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.jnj.com/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Post Market Surveillance Manager will perform work under minimal supervision to manage the Complaints investigation process of the Post Market Surveillance System, providing oversight and leadership of complaint investigations into serious incidents and non-serious incidents, to ensure timely MDR/MDV reporting, and maintaining compliance to quality objectives and procedures for timely complaint closure. This position includes managerial responsibility of the complaint investigators and requires frequent use and general knowledge of industry practices, techniques, and standards in compliance with applicable domestic and international Medical Device Post Market Surveillance regulations.

Requirements

• Bachelor's degree and a and minimum 5 years' experience with complaint investigations, and 10 years' experience with Medical Device Complaint handling, Post Market Surveillance and Regulatory reporting for Class II/III medical devices
• Risk management experience for Class II/III medical devices, with thorough knowledge of FMEAs and RMRs
• Minimum 2 years' prior management or other relevant experience
• Proficiency in data compilation, analysis, presentation, and document writing skills
• Excellent written and verbal communication skills
• Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems
• The ability to understand and follow QMS Procedures (e.g., SOP and Test Methods)
• Experience with computer-based applications (MS Word, MS Excel, QAD)
• Strong time management skills and the ability to multi-task in a fast-paced environment
• Ability to work in a fast-paced environment while managing multiple priorities
• Operate as a team and/or independently while demonstrating flexibility to changing requirements

Nice To Haves

• Related Quality System Certification is a plus
• Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus

Responsibilities

• Management of the assigned aspects of the Complaint Handling Process
• Ensure compliance of the Complaints System to internal requirements and Domestic and International Regulations.
• Ensure compliance with assigned complaint metrics and quality objectives (e.g. timeliness for complaint initiation, reportability assessments, MDR/MDV reporting, and investigation and closure of complaints)
• Maintain compliance with adverse event reporting determinations against domestic and international regulatory requirements which include but are not limited to the US, EU, Japan, Brazil, Australia, and Canada as it relates to the outcome of complaint investigations.
• Escalate high risk and unanticipated incidents to management as required.
• Review and approve complaint investigations within the Quality Management System (QMS) for completeness, which include complaint risk assessments, CAPA escalations, lot history record review (LHR), and device RMA return and investigation summary and conclusions, in an accurate and timely manner ensuring concise and grammatically correct English which is appropriate for regulatory review.
• Oversee daily responsibilities of Complaint Investigation Team
• Lead, manage, and develop members of the complaint investigation team within Post Market Surveillance
• Provide guidance on dealing with potentially reportable events or complaints with inadequate information.
• Ensure complaints are prioritized based on patient, product, and compliance risk.
• Closely monitor the complaint investigation process to ensure investigation prioritization in partnership with the applicable engineering teams, and timely device receipt and investigation.
• Present outputs of the complaints process and metrics to management as required by management
• Assist with training Customer and Shockwave Medical reps to ensure compliance with Shockwave Post Market Surveillance requirements.
• Ensure investigation methods and procedures are maintained in compliance with internal requirements and external regulations, and available prior to new product launches or geography introduction.
• Compile quality metrics for trending purposes
• Maintain QA related logs and databases (e.g. Complaints, Audit Findings etc.)
• Maintenance and compliance of the complaint handling module of the QMS as it relates to business needs (e.g. new products and geography introduction, etc.)
• Prepare reports on complaint trending, complaint metrics, post market surveillance activities, Periodic Safety Reports etc.
• Undertake continuous improvements of the Complaints and Post Market Surveillance System.
• On an ongoing basis, monitor adequacy of the Complaints and Post Market Surveillance System.
• Draft new procedures and System changes as needed to accommodate regulatory requirements for new country introductions.
• Ensure the Post Market Surveillance Systems are tied to Risk Management process.
• Identify and implement continuous improvement activities to enhance the Post Market Surveillance Systems.
• Participate in quality system activities and support internal and external audits.
• Work cross-functionally with other teams to compile and generate periodic reports in a timely manner to support Post Market Surveillance activities.
• Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.
• Other duties as assigned.

Benefits

• 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 Company's 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 of Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees