The function of a Clinical Evaluation Report Project Manager is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745. This role will support the Electrophysiology product line.
The CER PM is recognized as a subject matter expert for guidelines and regulations regarding the clinical evaluation process and its consequent documents (e.g., CEP, PMS/PMCF Plan, SSCP and PSUR, and CER). As such, this person has oversight of one or more CER Specialists guiding the development, or update, of CERs and CER-related documents. In addition, the Scientific CER PM will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk/benefit profile of a device or devices. Moreover, the Scientific CER PM may be requested to contribute to other activities such as risk assessment and management, and review of informational documents like the Instructions for Use. The Scientific CER PM also may sit in on core team product development, CER-related SOP development and revision, and interact with regulatory agencies’ representatives as needed.
The role of Scientific CER PM plays a significant part in new product development, as well as in the subsequent evaluation of the safety and performance of a device over its lifecycle. The position reports to the Director of Clinical Research Regulatory (CEP CER).
- Compliance with applicable corporate and divisional policies and procedures.
- Manage CER Specialists’ efforts in writing and editing of scientific content of deliverables, and the timelines of these documents.
- Write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, and other clinical CER deliverables.
- Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, Sales and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers).
- Provide strategic guidance on regulatory requirements to new product development teams and sustaining teams.
- Participate in and supportaudits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.
- Develop and update new policies, processes and SOPs for clinical evaluation process, and train key personnel on them.
- Function independently as a decision-maker on CER-related regulatory issues, and must assure thatdeadlines are met.
- Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., has understanding of research design, methodology, and statistics)
- A college degree (Bachelor’s) is required; post graduate degree (Masters or Doctorate) preferred.
- Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 3 and 4.
- Understanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, including: 21 CFR (e.g., 803, 812, 814, 820, 822, and 830); MDD 93/42/EEC; AIMDD 90/385/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
- Effective written, verbal and presentation skills in the area of technical/clinical applications.
- Strong command of medical and surgical terminology.
- Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), or Good Manufacturing Procedures (GMP) is preferred.
- Project management and/or management of people experience.
- 3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device or pharmaceuticals industry
- Experience in electrophysiology or other active implantable devices preferred.
- Demonstrated ability to identify and adapt to shifting priorities and competing demands.
- Highly-developed interpersonal skills, and strong attention to detail.
- Auditexperience (front room or back room) preferred.
- Certification is a plus (e.g., RAC and PMP).
- Able to travel as needed.