Global Post Market Surveillance (PMS) Specialist - Raynham, US
Corin, United States
Job Description
Corin is seeking a Global Post Market Surveillance Specialistto maintain and improve a compliant and effective post-market surveillance system, including but not limited to Development of Post Market Surveillance Plans and PMS reports, robust processes that feed PMS data into Risk Management process. The Global Post Market Surveillance Specialist will assure all Quality and Regulatory Compliance requirements for various Regulatory Agencies. Coordinate, analyze and report on voice of customer data from complaints, to aid in improving our products.
Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. Corin offers a unique combination of clinically proven hip amp; knee solutions and world leading technologies, our OMNIBotics amp; OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.
The main responsibilites of a Global Post Market Surveillance Specialist are to:
- Plan, manage and coordinate activities of the Post market department, through the establishment and management of the Post market team’s performance against departmental objectives and deliverables.
- Support design, develop, implement, and maintenance of a compliant and effective post-market surveillance system, including communication with the Food Drug Administration (FDA), Notified Bodies, and Competent or Regulatory Authorities for recalls, Medical Device Reports (MDRs) and periodic updates as back up
- Harmonise and maintain department procedures to reflect current regulatory requirements and department practices, and ensure they are followed.
- Serve as the expert on post-market surveillance activities (vigilance/adverse event reporting, PMS, PSURs, etc.), ensuring support through the decision-making activity, closure, and termination of issues.
- Prepare/oversee post-market surveillance (PMS) plans amp; publish PMS reports (timely) as per the EU MDR 2017/745
- Create trend reports for European regulatory bodies as per the EU MDR 2017/745
- Function as the subject matter expert for post-market surveillance during external audits/inspections by regulatory authorities.
- Drive continuous improvement and lean activities to improve efficiencies in post-market activities.
- Keep management informed of post-market feedback on products.
- Manage trends related to product complaints and relay information or concerns to Clinical team, Ramp;D team, and to upper management, including new product complaints.
- Ensure health hazard assessments / Risk Management are performed/updated for regulatory reporting of product problems according to regional requirements.
- Partner with Clinical team to provide PMS data/reports to support timely completion of CER reports.
- Participate in global complaint handling and field action discussions as deemed appropriate to faciliate coordination with regional impact of field actions.
- Provide appropriate input to Corrective and Preventative Actions (CAPA) program and Management Review as well as PS inputs to design and development teams.
- Interact with regulatory agencies regarding surveillance activities.
- Advise and guides management and other personnel in other departments on the interpretation and application of regulations impacting surveillance activities.
- Foster relationships with site and global Operations, Marketing, Product Development, Regulatory, Clinical, and Quality Assurance.Other activities involving Post Market Surveillance.
- Adherence to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS amp; Good Manufacturing Practice (GMP) FDA21 CFR Part 820.
- Ensure that process and timeline requirements for Corrective amp; Preventive Actions (CAPA) are met in accordance with Corin’s Standard Operating Procedures (SOPs) and in support of Corin’s Global Objectives for CAPA
Requirements
The ideal Global Post Market Surveillance Specialist will have / be:
- A Bachelor’s degree in Engineering, Life Science or a Bachelor’s degree and related experience.
- Experience in Quality Management or Regulatory in the medical device industry
- Experience with quality management and quality systems with knowledge and understanding of the Post Market Surveillance (PMS) requirements reflected in ISO 13485, Medical Device Directive (MDD) 93/42 EEC and EU MDR (2017/745), and the Quality System Regulations
- CAPA Experience in an FDA-regulated industry preferred
- Experience interfacing with competent authorities in charge of vigilance activities
- Initiative, b