- Title: Regulatory Project Manager (Clinical Evaluation Reports)
- Code: RCI-5645
- Location: Sylmar California (CA) 91342
- Posted Date: 10/08/2020
- Duration: 12 Months
- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
The primary function of a Regulatory Project Manager, Clinical Evaluations (“Clinical Evaluation Report (CER) Project Manager (PM)”) is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU 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, MDCG Guidance documents, and EU MDR 2017/745. This role will support the Cardiac Rhythm Management or Heart Failure product lines.
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, CER, PMS Plan, PMCF Plan, PMCF Report, and SSCP). As such, this person has oversight of internal and external CER Medical Writers, guiding the development, update, or revision of CERs and associated documents to support the ongoing evaluation of safety and performance of medical devices in the EU and other geographies that recognize the CE Mark. In addition, the 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 CER PM may be requested to contribute to other activities such as process improvement, risk assessment and management, and review of regulatory and informational documents such as the Clinical Development Plan (CDP), the Instructions for Use (IFU) and patient handbooks. The CER PM also may sit in on core teams for product development, CER-related procedure development and revision, and interact with regulatory agencies’ representatives as needed.
The role of the CER PM plays a significant part in new product development, as well as in the ongoing, continuous evaluation of the safety and performance and risk/benefit profile of a device over its lifecycle. The position reports to the Global Regulatory Operations Program Director for Clinical Evaluations.
- Compliance with applicable corporate and divisional policies and procedures.
- Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents; set deliverable and project timelines and ensure timelines are met.
- Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).
- Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents.
- Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions.
- Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams.
- Participate in and support internal and external audits 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, as appropriate, for processes and procedures relating to the clinical evaluation process, and train key personnel on them.
- Function independently as a decision-maker on CER-related regulatory issues.
- Scientific/research background; training and degree in science, engineering, or medical fields; understanding of research design, methodology, and statistics.
- 5-7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry.
- 3-5+ years of experience writing, reviewing or leading development of CERs and related documents in accordance with MEDDEV 2.7/1 Rev 3 and 4, the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745.
- Must have thorough understanding of the EU MDR 2017/745, MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev 4, MDCG Guidances on clinical evaluations, SSCP, PMCF plans and reports, and other international harmonized standards and guidelines related to medical devices, clinical studies, and quality systems.
- Experience in the area of complex, high-risk medical devices in Cardiac Rhythm Management or Heart Failure, or other active implantable devices preferred.
- Project management and/or management of people experience.
- A college degree (Bachelor’s) is required; Master’s Degree, RN, PharmD, PhD, or MD preferred.
- Excellent written, verbal and presentation skills in relevant areas of clinical/technical applications.
- Strong command of medical and surgical terminology.
- Demonstrated ability to identify and adapt to shifting priorities and competing demands.
- Highly-developed interpersonal skills, and strong attention to detail.
- Audit experience (front room or back room) preferred.
- Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), or Good Manufacturing Procedures (GMP) is preferred.
- Certification is a plus (e.g., RAC and PMP).
- Able to travel as needed (<10%).