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

Abbott • Pleasanton, SC

1d • Onsite

About The Position

Abbott Medical Devices is seeking a Senior Project Manager/Clinical Evaluation Reporting to join their team. This role is crucial for supporting Regulatory Affairs in the EU for CE Marking of new and existing medical devices, in accordance with EU MDR 2017/745 and related guidelines. The position primarily supports Heart Failure product lines and requires expertise in clinical evaluation processes and documentation. The role involves overseeing internal and external Medical Writers, guiding the development of Clinical Evaluation Reports (CERs) and associated documents, and ensuring the ongoing safety and performance evaluation of Abbott's medical devices. The CER PM will collaborate cross-functionally to gather necessary documentation and may contribute to process improvements, risk assessments, and reviews of regulatory documents. This position plays a significant role in new product development and the continuous evaluation of device safety and performance throughout its lifecycle.

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 non-compliance 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

• 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
• Health and wellness benefits

What This Job Offers

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