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

Abbott Laboratories • Pleasanton, CA

2d • $90,000 - $180,000 • Onsite

About The Position

The Senior Project Manager/Clinical Evaluation Reporting role is within Abbott's Medical Devices team, focusing on supporting Regulatory Affairs for EU CE Marking. This position requires a deep understanding of scientific methodology, medical device regulations (EU MDR 2017/745, MEDDEV 2.7/1 Rev 4, MDCG Guidance), and product knowledge to manage the creation and updating of Clinical Evaluation Reports (CERs) and associated documents. The role primarily supports the Heart Failure product lines and involves guiding internal and external medical writers, collaborating cross-functionally to gather safety and performance data, and contributing to process improvements and risk assessments. This position is crucial for both new product development and the continuous lifecycle evaluation of medical devices, ensuring ongoing safety, performance, and benefit/risk profiles are maintained. The role 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 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.
• Comprehensive experience developing and authoring Clinical Evaluation Plans and Clinical Evaluation Reports.
• 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