Senior Project Manager/Clinical Evaluation Reporting (on-site)

Abbott • Pleasanton, CA

2d • $90,000 - $180,000 • Onsite

About The Position

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 EU MDR 2017/745, MEDDEV 2.7/1 Rev 4, MDCG Guidance documents, and predicate MDD and AIMDD directive requirements. This role will primarily support the 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 Abbott medical devices in the EU and other geographies that recognize the CE Mark. Scientific / Medical writing experience is required. 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 Global Regulatory Operations Senior Principal Scientist for Clinical and Risk Evaluations.

Requirements

• Bachelor’s degree in a related field or an equivalent combination of education and experience.
• Minimum 6 years’ related work experience with a strong understanding of specified functional area.
• Solid understanding and application of business concepts, procedures and practices.
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Has a sound knowledge of a variety of alternatives and their impact on their business unit.
• Scientific / Medical writing experience is required.

Nice To Haves

• Master’s Degree, RN, PharmD, PhD, or MD
• Scientific/research background; training and experience in science, engineering, or medical fields; understanding of research design, study methodology, and statistics; experience in the medical device industry.
• Must have comprehensive experience developing and authoring Clinical Evaluation Plans and Clinical Evaluation Reports.
• Must have thorough understanding of the EU MDR 2017/745, MDCG Guidance on clinical evaluations, related Standards, MEDDEV 2.7/1 Rev 4, , SSCP, PMCF plans and reports, and other guidance, regulations, standards and guidelines related to medical devices, clinical studies, and quality systems.
• 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 the EU MDR 2017/745, relevant Standards and MDCG documents, MEDDEV 2.7/1 Rev 4, and the predicate medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC).
• Excellent written and verbal skills, and presentation skills in the area of technical/clinical applications.
• Experience with EN ISO 13485, EN ISO 14155 EN ISO 14971.
• Experience with high risk (Class III) medical devices in Heart Failure, or other active implantable devices.
• Project management and/or management of people experience.
• Certification is a plus (e.g., RAC and PMP).
• Audit experience (front room or back room).

Responsibilities

• Compliance with applicable corporate and divisional policies and procedures.
• Lead projects and provide guidance and oversight to CER Medical Writers in writing 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 Reports and associated documents, including providing detailed evaluation of clinical data from clinical studies, literature, and post-market surveillance.
• 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, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).
• 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 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.

Benefits

• Career development with an international company where you can grow the career you dream of
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

What This Job Offers

• Job Type: Full-time
• Career Level: Senior