Senior Project Manager, Clinical Evaluation

Abbott; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Abbott is seeking a Regulatory Project Manager, Clinical Evaluations (CER PM) in Sylmar, CA. This role combines scientific methodology, device regulations, and product knowledge to support EU CE marking submissions and ongoing CE maintenance for Abbott medical devices.

The CER PM will lead CER writers, guide CER development, and collaborate with Regulatory Affairs, R&D, and Quality teams to ensure safety and performance data supports regulatory decisions.

Qualifications

• Bachelor's degree in sciences, medicine, or similar field required.
• Minimum 3 years of scientific or research background with relevant training.

Responsibilities

• Ensure CER processes align with regulatory requirements and guidelines.
• Oversee CER Medical Writers and manage timelines for deliverables.
• Review and edit sections of Clinical Evaluation Reports and related documents.
• Lead regulatory responses to Notified Body questions.
• Coordinate document exchange among Regulatory Affairs, R&D, Clinical, and QA teams.
• Provide strategic regulatory guidance on clinical data for new products.
• Support audits and corrective action tracking related to CER processes.
• Develop and update CER-related policies and train staff.

Skills

Regulatory knowledge

Medical writing oversight

Cross-functional collaboration

Project management

CER / clinical evaluation

Education

Bachelor's degree in sciences/medicine

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Our location Sylmar, CA currently has an opportunity for a Project Manager, Clinical Evaluation.

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 MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG Guidance documents, and EU MDR 2017/745. This role will support the Cardiac Rhythm Management 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. In addition, the CER PM will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk/benefit 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) and patient handbooks. 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 risk/benefit profile of a device over its lifecycle. The position reports to the Global Regulatory Operations Senior Manager for Clinical Evaluations.

WHAT YOU'LL DO

• Compliance with applicable corporate and divisional policies and procedures.
• Manage CER Medical Writers' in writing and editing content of documents, and the timelines of these deliverables; must assure timelines are met.
• 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.
• 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.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

• Bachelor's Degree is required. in sciences, medicine, or similar discipline highly preferred. Or an equivalent combination of education and work experience.
• Minimum 3 years : Scientific/research background; training and degree in science, engineering, or medical fields; understanding of research design, methodology, and statistics.