The Opportunity

Our location in Plano, TX, Austin, TX, Santa Clara, CA, Sylmar CA or Maple Grove, MN currently has an opportunity for a Clinical Evaluation - Senior Project Manager . This new team member will 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. What You’ll Work On 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. Compliance with applicable corporate and divisional policies and procedures. 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. Required Qualifications Bachelor’s Degree Minimum 2 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Minimum 3 years of experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience. Principles and requirements of applicable product laws Ethical guidelines of the regulatory profession, clinical research and regulatory process Create and manage project plans and timelines Think analytically, pay strong attention to detail, organize and track complex information Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues. Preferred   Qualifications Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields. Advanced degree Scientific/research background; training and degree in science, engineering, or medical fields; understanding of research design, methodology, and statistics. 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. Project management and/or management of people experience. Strong 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. 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. Certification is a plus (e.g., RAC and PMP).