The PMS/CER Manager ensures compliance with national and international regulations with regards to Post Market Surveillance (PMS) & Clinical Evaluation Report (CER) activities. They will direct the planning, preparation and facilitates the timely submissions of all PMS & CER reports to the appropriate regulatory authorities globally. They will be responsible for consistent, thorough, timely PMS & CER outputs as required by established procedures. They will ensure development of post market surveillance plans and delivery of PMS Reports, including Post Market Clinical Follow-Up (PMCF and associated activities), and Clinical Evaluation Plans and Reports (CEPs, CERs). This is an individual contributor role.
DUTIES & RESPONSIBILITIES
- Maintain an excellent understanding of global medical device regulations in relation to Post Market Surveillance (PMS Plans and Reports), Post Market Clinical Follow Up (PMCF checklists and plans), Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs).
- Coordinate the PMS Reports by product family and support the generation and update of PMS plans.
- Coordinate with cross functional teams to ensure timely data gathering, analysis, conclusions and reports are delivered on schedule as per Regulatory requirements.
- Develop, maintain, and adhere to the scheduling and management of PMS plans and reports, PMCF plans and reports and clinical evaluations.
- Liaise and advise other functional units (R&D, Quality, Regulatory, Marketing, etc.) of the relevant requirements for PMS, CER and PMCF and ensure the outputs from the individual functional units meet the applicable regulatory requirements. Review and analyze data for same.
- Author and coordinate of PMS Reports summarizing data and coordinating analysis and conclusions drawn with Cross Functional Team.
- Author and coordinate Clinical Evaluation Plans and Clinical Evaluation Reports.
- Author and coordinate PMCF Checklists, PMCF plans and PMCF activities (e.g., studies, investigations etc.).
- Provide critical thinking and analysis of conclusions drawn on PMS reports (e.g., Summarized PMS Data, Proactive Data, Trends) as part of the PMS report approval process to ensure intent of the Regulations is being met.
- Participate, as required, in PMS development projects and support project deliverables as needed.
- Provide input to PMS, risk assessment and CER interdependency strategies.
- Communicate directly with Notified Bodies, Competent Authorities and other Regulatory Authorities as required.
- Develop global PMS/CER procedures and forms.
- Perform additional duties as assigned.
- Bachelor's degree or equivalent work-related experience.
- 5+ years' experience in a regulated industry in a similar role.
- Knowledge of regulations pertaining to PMS, PMCF and CERs particularly in relation to the EU (MDD & MDR regulations).
- Knowledge of medical device quality standards/practices or similar regulated industry
- Ability to manage priorities and workflow in a rapidly changing environment
- Experience working in a cross-functional team environment
- Excellent organizational, problem-solving, and analytical skills
- Excellent verbal & written communication skills
- Must be able to work with minimal supervision.
- Excellent computer skills, including MS Office and Windows, for word processing, spreadsheet, and presentation software.
- Excellent interpersonal and communication skills with the ability to develop trust, respect, and confidence with internal and external customers.
- High level of integrity and work ethic.
- Knowledge / use of search databases for published literature (Embase, MEDLINE etc.)
- Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System
- Experience in the orthopedic industry
- Drives results
- Optimizes work processes
- Decision Quality
- Problem Solving
- Critical Thinking
- Communicates Effectively
- Manages Complexity
PHYSICAL DEMANDS & WORK ENVIRONMENT
- Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
- Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
- Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
- Occasionally work around moving mechanical parts.
- Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
- Must be able to travel as business necessitates (up to 10%).
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made possible to enable individuals with disabilities to perform the essential functions.