Project Manager II

Project Manager, Clinical Evaluation 
Contract - 12 + months

Our location in Plano, TX currently has an opportunity for a Project Manager, Clinical Evaluation supporting the Neuromodulation medical device business unit.

SUMMARY:
The primary function of a Clinical Evaluation (“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 Neuromodulation 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 including data on safety, performance, adverse events and benefit/risk 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). 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 benefit/risk profile of a device over its lifecycle. The position reports to the Senior Manager, NMD Clinical Evaluations within Global Regulatory- Clinical and Risk Evaluation.

MAIN RESPONSIBILITIES 

• Lead projects and provide guidance and oversight to Internal Medical Writers and vendors in authoring and editing content of documents; manage timelines of these deliverables; must assure timelines are met. 
• Review, edit, and write portions, as needed, of Clinical Evaluation Plans and Reports and associated documents. 
• Compliance with applicable corporate and divisional policies and procedures. 
• Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions. 
• Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, A&P and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Program Management, and Internal Medical Writers, as well as external vendors such as CROs, contract Medical Writers and consultant Physician Reviewers). 
• Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development and sustaining product teams. 
• Participate in and support audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics. 
• Contribute to developing and/or updating processes and procedures relating to the clinical evaluation process. 
• Function independently as a decision-maker on CER-related regulatory issues.

JOB REQUIREMENTS

Required 

• Bachelor’s Degree is required; in the sciences, engineering, health care/medicine, or similar discipline highly preferred. 
• 5+ years experience in science, engineering, or medical fields; understanding of clinical research design, study methodology, and statistics; experience in the medical device industry. 
• 3-5+ years experience developing and authoring Clinical Evaluation Plans and Clinical Evaluation Reports.
• 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 Guidance on clinical evaluations, SSCP, PMCF plans and reports, and other guidance, regulations, standards and guidelines related to medical devices, clinical studies, and quality systems.
• Project management (including experience with project management software) and/or management of people experience preferred. 
• Excellent written and verbal skills in the English language, and presentation skills in the area of technical/clinical applications. 
• Strong command of clinical, 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. 
• Able to travel as needed (<10%).

Preferred 

• Master’s Degree, RN, PharmD, PhD, or MD preferred. 
• Experience with EN ISO 13485, EN ISO 14155 EN ISO 14971 is preferred. 
• Experience with high risk (Class III) medical devices in Neuromodulation, or other active implantable devices preferred. 
• Certification is a plus (e.g., RAC and PMP). 
• Audit experience (front room or back room) preferred. 
• 3-5+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry. 
• 1-3+ years of experience writing, reviewing or leading development of CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4, the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745.

LS Solutions is a privately owned minority certified niche consulting and managed solutions firm head quartered in Princeton, NJ servicing Life Sciences industry with international office locations in India, Singapore, Germany, Belgium and United Kingdom.