At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We are currently recruiting for a Senior Analyst, Post Market Complaints to be located in Horsham, PA.
Janssen Supply Group, LLC is a global organization responsible for producing and supplying medicines to markets around the world. With quality as its primary focus, this group collaborates with Research & Development and Commercial partners to deliver life-changing solutions for patients in need.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Senior Analyst, Post Market Complaints will:
- Be responsible for performing high-volume complaint handling activities and medical device regulatory reporting; they also may be responsible for managing team processes to ensure productivity and accuracy.
- Provide instruction and feedback to the group as needed and ensure completeness and consistency of complaint and Regulatory reporting documentation.
- Possess strong complaint handling experience (i.e. 21CFR 820.198, 21CFR 211) and working knowledge/experience with regulatory reporting requirements for medical devices (i.e. 21CFR 803). Additionally, international medical device regulatory reporting expertise is strongly desired (i.e. CMDR, Meddev 2.12, etc.).
- Perform high-volume complaint activities that include device MDR evaluations and submissions, coding, dispositions, etc.
- Write, review, and file Medical Device Reports (MDRs) and potentially Vigilance Reports (i.e. MDV, MPR) as required. This includes on-time filing of initial and supplemental regulatory reports.
- Prepare responses to Regulatory agency requests for additional information (i.e FDA MDR inquiries)
- Ensure that uniform and timely management of complaint records, investigations and regulatory reporting occurs per procedures, standards and regulations.
- Create customer response letters upon request.
- Develop and deliver appropriate training (i.e. process, complaint handling, and regulatory reporting) to complaint management system end users.
- Exhibit strong ability to collaborate and influence Business Partners (Internal JSC Manufacturing sites, External Business Partners, regional ESIQ organizations, Call Intake Centers, and Global Medical Safety/LSOs, Brand Protection, etc) to ensure appropriate complaint handling and improved complaint management processes.
- Facilitate, lead and collaborate with Central Complaint Vigilance (CCV) Reporting and Surveillance on New Product Introduction Processes.
- Serve as a CCV point person for post market and complaint handling regulatory questions and inquiries; provides guidance and direction to subordinate Analyst roles and other CCV functions.
- Support internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory inspections.
- A minimum of a Bachelor’s degree or equivalent in technical, life sciences, or engineering discipline is required.
- A Registered Nurse, Physician Assistant, Biomedical Engineer or other related license/certification/degree is highly preferred but not mandatory.
- A minimum of 6 years of professional experience is required.
- Experience working with post market/complaint handling activities is required.
- Direct experience in a high-volume complaint handling unit with medical device reporting responsibilities is preferred.
- Prior lead or Lead/Supervisory experience is preferred.
- Strong knowledge and understanding of regulatory requirements listed below is highly preferred: ISO 9001/13485/14971, FDA Regulations (21CFR (210, 211, 803, 806, 820, part 11, part 4, 210, 211, etc.)), ICH Q8, 9 & 10, CMDR, JPAL, and Medical Devices Directive (93/42/eec, 98/79/EC)).
- The position will be based in Horsham, PA
- This position may require up to 10%-15% travel depending on business needs.
JANSSEN SUPPLY GROUP, LLC (6046)Job Function