The Senior Post Market Surveillance Manager will be responsible for leading and developing Post Market Surveillance (PMS), Post Market Clinical Follow-Up (PMCF), and Clinical Evaluation Plans and Reports (CEPs, CERs) for Cook Inc. This role will lead the team in gathering, analyzing and reporting on the field activities and clinical performance and safety of our devices.
- Maintain an excellent understanding of global medical device regulations in relation to Post Market Surveillance (PMS), Post Market Clinical Follow Up (PMCF), Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) and responsibility for implementing regulatory requirements in accordance with ISO13485, MDR 2017/745, 21CFR Part 820 and others as required.
- Oversee the scheduling and management of PMS plans and reports, PMCF plans and reports and clinical evaluations. Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
- Liaise and advise other Cook functional units (Engineering, Quality, Divisions,Clinical etc) of the relevant requirements for PMS and PMCF and ensures the outputs from the individual functional units meet the applicable regulatory requirements.
- Collaborate with other stakeholders and teams to implement and improve policies, processes, programs, and directives.
- Identify opportunities and lead the implementation of changes to drive improvements.
- Define effective and efficient business process workflow, including process modifications in partnership with stakeholders.
- Create a High-Performing Team by establishing clear requirements and goals within the team.
- Act as a Subject Matter Expert (SME) and train, develop, and mentor new and existing managers and employees.
- Drive accountability and recognition through performance conversations, coaching, and other tools.
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
- Ability to remain calm and receptive in fast paced situations.
- Bachelor's degree in a life science or other related field.
- Post-graduate degree in a life science preferred.
- 7 years regulatory experience required; preferably in the medical device field
- Proven project leadership skills.
- Demonstrated ability to provide consistent leadership in a team setting.
- Demonstrated ability to manage conflict, communication and resources across multiple projects.
- Demonstrated ability to lead teams with a large scope of initiatives.
- Requires occasional early morning or evening teleconferences.
- Must be willing and able to travel as needed.
- Works under general office environmental conditions.
- Sits for extended periods, utilizes close visual acuity for working with computers, etc.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA